Panther Group Of Surgical Includes: Oanther Circular Stapler +2 more models
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- PANTHER Linear Stapler EUDAMEDPANTHER Circular stapler EUDAMEDCircular Stapler FDA UDI
- Generic Name
- Intraluminal circular stapler, single-use FDA UDI
- Device Name
- Linear Stapler EUDAMEDCircular stapler EUDAMED
- Model / Reference
- FCSSME34 EUDAMEDFDA UDIFCSSWAE31 EUDAMEDFDA UDIFCSME34 EUDAMEDFDA UDIFCSSWBE32 EUDAMEDFDA UDIFCSME26 EUDAMEDFDA UDIFCSME24 EUDAMEDFDA UDIFCSSWBE31 EUDAMEDFDA UDIFCSSME32 EUDAMEDFDA UDIFCSSWAE33 EUDAMEDFDA UDIFLSL90 EUDAMEDFCSLWAF32 EUDAMEDFCSS33 EUDAMEDFCSLWAE29 EUDAMEDFLSLG90 EUDAMEDFCSLWAF25 EUDAMEDFLSLG60 EUDAMEDFCSS36 EUDAMEDFCSLWBF33 EUDAMEDFCSM26 EUDAMEDFCSMF25 EUDAMEDFCSSWAF34 EUDAMEDFCSLWBF34 EUDAMEDFCSSWAF26 EUDAMEDFCSMF28 EUDAMEDFCSSWBF21 EUDAMEDFCSSWBE36 EUDAMEDFCSLWAE26 EUDAMEDFLSLF60 EUDAMEDFLSL30 EUDAMEDFCSSWBF29 EUDAMEDFCSSWBF24 EUDAMEDFCSM29 EUDAMEDFCSMF29 EUDAMEDFCSMF24 EUDAMEDFCSSMF26 EUDAMEDFCSLWBF21 EUDAMEDFCSM25 EUDAMEDFCSMF26 EUDAMEDFCSS32 EUDAMEDFLSLE90 EUDAMEDFCSME21 EUDAMEDFCSM24 EUDAMEDFCSLWAE32 EUDAMEDFCSSWAF21 EUDAMEDFLSL60 EUDAMEDFCSLW26 EUDAMEDFCSMED25 EUDAMEDFLSLE45 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939282438611 EUDAMEDFDA UDI06939282438505 EUDAMEDFDA UDI06939282448740 EUDAMEDFDA UDI06939282438550 EUDAMEDFDA UDI06939282448719 EUDAMEDFDA UDI06939282448702 EUDAMEDFDA UDI06939282438543 EUDAMEDFDA UDI06939282438598 EUDAMEDFDA UDI06939282438529 EUDAMEDFDA UDI06939282499117 EUDAMED06939282401479 EUDAMED06939282438383 EUDAMED06939282418521 EUDAMED06939282499230 EUDAMED06939282401455 EUDAMED06939282499223 EUDAMED06939282438192 EUDAMED06939282401547 EUDAMED06939282448283 EUDAMED06939282448672 EUDAMED06939282438796 EUDAMED06939282401554 EUDAMED06939282438734 EUDAMED06939282448665 EUDAMED06939282438802 EUDAMED06939282438765 EUDAMED06939282418514 EUDAMED06939282499186 EUDAMED06939282499087 EUDAMED06939282438840 EUDAMED06939282438819 EUDAMED06939282448481 EUDAMED06939282448771 EUDAMED06939282448757 EUDAMED06939282403732 EUDAMED06939282401509 EUDAMED06939282448184 EUDAMED06939282448764 EUDAMED06939282438086 EUDAMED06939282499155 EUDAMED06939282446753 EUDAMED06939282448085 EUDAMED06939282418538 EUDAMED06939282438772 EUDAMED06939282499100 EUDAMED06939282418187 EUDAMED06939282448832 EUDAMED06939282499131 EUDAMED
- Basic UDI-DI
- B-06939282499117 EUDAMEDB-06939282401479 EUDAMEDB-06939282438383 EUDAMEDB-06939282418521 EUDAMEDB-06939282499230 EUDAMEDB-06939282401455 EUDAMEDB-06939282499223 EUDAMEDB-06939282438192 EUDAMEDB-06939282448740 EUDAMEDB-06939282401547 EUDAMEDB-06939282448283 EUDAMEDB-06939282448672 EUDAMEDB-06939282438796 EUDAMEDB-06939282401554 EUDAMEDB-06939282438734 EUDAMEDB-06939282438529 EUDAMEDB-06939282448665 EUDAMEDB-06939282438802 EUDAMEDB-06939282438765 EUDAMEDB-06939282418514 EUDAMEDB-06939282499186 EUDAMEDB-06939282499087 EUDAMEDB-06939282438840 EUDAMEDB-06939282438819 EUDAMEDB-06939282448481 EUDAMEDB-06939282448771 EUDAMEDB-06939282438543 EUDAMEDB-06939282448757 EUDAMEDB-06939282403732 EUDAMEDB-06939282401509 EUDAMEDB-06939282448184 EUDAMEDB-06939282438598 EUDAMEDB-06939282448764 EUDAMEDB-06939282438550 EUDAMEDB-06939282438086 EUDAMEDB-06939282438611 EUDAMEDB-06939282499155 EUDAMEDB-06939282446753 EUDAMEDB-06939282448085 EUDAMEDB-06939282418538 EUDAMEDB-06939282448719 EUDAMEDB-06939282438772 EUDAMEDB-06939282499100 EUDAMEDB-06939282418187 EUDAMEDB-06939282448832 EUDAMEDB-06939282499131 EUDAMEDB-06939282448702 EUDAMEDB-06939282438505 EUDAMED
- 510(k) Number
- K103470 FDA 510(k)
- FDA Product Code
- GDW FDA 510(k)FDA UDI
- EMDN Code
- H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMEDH0202020201 SINGLE-USE CURVED CIRCULAR STAPLERS FOR OPEN SURGERY EUDAMED
- GMDN Term
- Intraluminal circular stapler, single-use FDA UDI
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4750 FDA 510(k)
- Regulation Number
- 878.4750 FDA 510(k)FDA UDI
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
The Panther Circular Stapler, Panther Hemorrhoidal Circular Stapler, and Panther Linear Stapler are surgical stapling devices designed for tissue approximation and resection. These instruments use titanium staples to create secure anastomoses or excise tissue in a controlled manner. The circular staplers are specifically engineered to form circular connections in tubular structures, while the linear staplers provide precise cutting and stapling along straight tissue planes. All models are manual, single-use devices intended for open or laparoscopic procedures.
These devices are supplied sterile and intended for single-patient use. The Panther Circular Stapler applies double or triple staggered rows of titanium staples while simultaneously resecting tissue, forming a circular anastomosis. The Panther Hemorrhoidal Circular Stapler is tailored for hemorrhoidal procedures, and the Panther Linear Stapler offers cutting and stapling functionality. They are classified as Class II devices under FDA regulations and comply with the Medical Device Directive (MDD). These instruments are not MRI-compatible and must be stored as per manufacturer guidelines to maintain sterility.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Panther Group of Surgical Includes: Oanther Circular Stapler; Panther ..., PDF Product Catalog - Panther Healthcare USA, PDF A J.4 1 01 - Food and Drug Administration
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K103470 | Class II | Active |
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Manufacturer
- Manufacturer
- B. J. ZH. F. Panther Medical Equipment Co., Ltd.
- FDA Applicant
- B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
Sources (58)
- FDA 510(k) K103470 24 fields · synced Sep 30, 2026
- FDA UDI b4c769c7-c30c-4a98-952d-29947158e347 32 fields · synced May 29, 2026
- FDA UDI 2788f97e-4966-4a99-a66c-3851e48a9aa8 32 fields · synced May 29, 2026
- FDA UDI 892213c9-9022-4db0-a942-0277c6364a69 32 fields · synced May 30, 2026
- FDA UDI 3aabbf74-f53c-4e67-b0cb-408c0da200a2 32 fields · synced May 30, 2026
- FDA UDI 734aa1eb-d8c7-473e-a8b8-d0268e2ea485 32 fields · synced May 30, 2026
- FDA UDI c13330de-4f34-4614-8f96-46460894c91e 32 fields · synced May 30, 2026
- FDA UDI e1df1975-1575-4c52-ad6e-99691000fc22 32 fields · synced May 30, 2026
- FDA UDI 02cbb913-7b76-46c1-b378-4031d2b684d4 32 fields · synced May 30, 2026
- FDA UDI 00655d60-db74-4e11-bf16-6c4747c10952 32 fields · synced May 30, 2026
- EUDAMED c0467e69-9299-4692-a780-4365a24edea0 61 fields · synced Jul 8, 2026
- EUDAMED 696ccd39-36e8-4b2c-8c47-b45e32ecab03 61 fields · synced Jul 9, 2026
- EUDAMED dc7529d1-aff8-4a59-9732-579ef418fc24 61 fields · synced Jul 9, 2026
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- EUDAMED de927cfa-eaef-48c8-a237-dcbd0f5baa5b 61 fields · synced Jul 10, 2026
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- EUDAMED 8965b784-45a8-423e-8ca6-1d86c4f07dbd 61 fields · synced Jul 10, 2026
- EUDAMED 476df12e-d837-401f-9b39-82d15e56696a 61 fields · synced Jul 10, 2026
- EUDAMED bbf23fa7-e158-48d2-bf5d-88356eecb38a 61 fields · synced Jul 11, 2026
- EUDAMED 96a1a74c-a55b-4c5e-82c7-2922589dbdcb 61 fields · synced Jul 11, 2026
- EUDAMED 2b640402-d006-4783-94f0-757a92dee02b 61 fields · synced Jul 11, 2026
- EUDAMED b2167e9e-1c17-4447-9d6d-8cabc7cff1f6 61 fields · synced Jul 12, 2026
- EUDAMED 2b02138b-997d-46cc-8c48-11e625b7d31f 61 fields · synced Jul 12, 2026
- EUDAMED 73b9234f-7b9d-4c70-8684-eb52f71be588 61 fields · synced Jul 12, 2026
- EUDAMED 32ff3980-f991-4d46-848d-57b81573de76 61 fields · synced Jul 12, 2026
- EUDAMED b4dacc51-083d-46b9-9ecd-82f9e2a6c0d0 61 fields · synced Jul 13, 2026
- EUDAMED 20baeaac-c514-4909-b10b-b09b931629db 61 fields · synced Jul 13, 2026
- EUDAMED 6ead9863-9f55-49a7-a6b9-24aa7605fb80 61 fields · synced Jul 13, 2026
- EUDAMED cdfc5a62-e004-4ad2-b177-e3dcf8e01a2a 61 fields · synced Jul 14, 2026
- EUDAMED c40eb031-3c84-4e93-bc45-c5ecfa2650f9 61 fields · synced Jul 14, 2026
- EUDAMED d7fbfcfe-b3ab-468c-b182-f44bd7b3c003 61 fields · synced Jul 14, 2026
- EUDAMED 534c403c-3b04-4ff0-9b48-94390578da91 61 fields · synced Jul 14, 2026
- EUDAMED 1aa55b14-8430-4399-961a-525990b4999e 61 fields · synced Jul 16, 2026
- EUDAMED 5d6ecff0-8292-4f0e-8498-1e675be2188e 61 fields · synced Jul 16, 2026
- EUDAMED be3a218b-cac8-4190-9e55-68aab310ad1d 61 fields · synced Jul 17, 2026
- EUDAMED c7546d3d-72f0-486e-981e-e33607561f59 61 fields · synced Jul 17, 2026
- EUDAMED e8c0fd22-9c09-4b19-859a-7f52728c6a24 61 fields · synced Jul 17, 2026
- EUDAMED e4f99cf2-5df3-46b1-8076-fc1c8ceae6fd 61 fields · synced Jul 18, 2026
- EUDAMED 6829a89f-e43d-4380-a7bb-03230cd6a120 61 fields · synced Jul 19, 2026
- EUDAMED a399aa7f-327a-4982-a8b8-428c089c608c 61 fields · synced Jul 20, 2026
- EUDAMED 573eae50-1b84-4083-a038-b5aa61a4344d 61 fields · synced Jul 21, 2026
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- EUDAMED 29f1483a-8e5a-4e16-9e8e-4fe88f744f7b 61 fields · synced Jul 23, 2026
- EUDAMED 2ab45331-d678-4d86-9f4e-87ed9cb102b4 61 fields · synced Jul 24, 2026
- EUDAMED 99a836b9-9d7c-435c-935c-39795b4d7a91 61 fields · synced Jul 24, 2026
- EUDAMED 480bbe71-031e-4412-b3bb-c15af8c1c818 61 fields · synced Jul 26, 2026
- EUDAMED 807ba62f-73b9-40de-b413-b58b68336e4b 61 fields · synced Jul 29, 2026
- EUDAMED df172ea2-cd6e-4116-a8fc-8a0a7dde8b05 61 fields · synced Jul 30, 2026
- EUDAMED 37c0a9d3-4a24-48de-a6ff-b9346e6d7bfb 61 fields · synced Jul 30, 2026
- EUDAMED 6d5c4139-bb48-412d-899c-2ebf5ad179cd 61 fields · synced Jul 30, 2026
- EUDAMED a9444cd5-6640-49c2-a6d4-f214a8555a08 61 fields · synced Jul 30, 2026
- EUDAMED 29c2e057-277e-4420-add8-e5cbf6183e05 61 fields · synced Jul 30, 2026
- EUDAMED e171100a-5aae-46b8-891d-b2a4215bf3d3 61 fields · synced Aug 2, 2026
- EUDAMED 443bd872-0ec6-4209-8f4b-4a34471f8196 61 fields · synced Aug 4, 2026
- EUDAMED 3fba857f-81ed-4f51-b6f8-46b381f3dc55 61 fields · synced Aug 4, 2026
- EUDAMED ae0e27f7-c8f5-48b0-95b1-355ac98bcb1d 61 fields · synced Aug 4, 2026
- EUDAMED e6db479a-b71d-469d-91ca-7e74f9005798 61 fields · synced Sep 18, 2026
- EUDAMED 1257461e-b990-4a18-a7a8-d7159a732a12 61 fields · synced Sep 18, 2026