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Endoscopic Instrument - Grasper
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref DI-5670-33DModel DI Series510(k) K240334
Identity
- Trade Name
- Endoscopic Instrument - Grasper EUDAMEDLAGIS FDA UDI
- Generic Name
- Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
- Device Name
- Endoscopic Instruments - Grasper EUDAMED5mm x 330 mm Endo-Clinch Grasping Forceps, Double Action FDA UDI
- Model / Reference
- DI Series EUDAMEDDI-5670-33D EUDAMEDFDA UDI
- Description
- 5mm x 330 mm Endo-Clinch Grasping Forceps, Double Action FDA UDI
Identifiers
- Catalog Number
- DI-5670-33D FDA UDI
- Primary DI / UDI-DI
- 04714123021465 EUDAMEDFDA UDI
- Basic UDI-DI
- 471412302DI-02QB EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01020104 MINIMALLY INVASIVE SURGERY FORCEPS, SINGLE-USE EUDAMED
- GMDN Term
- Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Endoscopic Instrument - Grasper by Lagis Enterprise Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240334 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 471412302DI-02QB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lagis Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000007081
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 017670ee-e77a-4422-8e64-5e06e2fc5475 85 fields · synced Jun 18, 2026
- FDA UDI 57537604-8d07-4601-bd7e-2b9fd3acc4a2 35 fields · synced May 30, 2026
- FDA 510(k) K240334 1 fields · synced May 18, 2026