ClearGrasp Snare
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- ClearGrasp Snare EUDAMEDFDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Single-use Endoscopic Polypectomy Snare EUDAMED24mm/ Moderato/ Oval/ Non-Rotation FDA UDI6mm/ Moderato/ Oval/ Rotation FDA UDI
- Model / Reference
- FM-ESN002(2400)(moderato)A EUDAMEDFDA UDIFM-ES0006(2400)(moderato)A EUDAMEDFDA UDIFM-ES0006(Cold)(2400)(0.3)D EUDAMEDFM-ESN004(Crescent)(2400)(Soft)D EUDAMEDFM-ES0005(2400)(Moderato)D EUDAMEDFM-ESN002(2400)(Moderato)D EUDAMEDFM-ESN006(2400)(Stiff)D EUDAMEDFM-ESN006(Cold)(2400)(0.3)D EUDAMEDFM-ES0003(2400)(Moderato)D EUDAMEDFM-ESN004(2400)(Soft)D EUDAMEDFM-ES0004(2400)(Moderato)D EUDAMEDFM-ES0002(2400)(Moderato)D EUDAMEDFM-ESN005(2400)(Moderato)D EUDAMEDFM-ESN006(2400)(Soft)D EUDAMEDFM-ESN004(Crescent)(2400)(Stiff)D EUDAMEDFM-ESN005(Crescent)(2400)(Soft)D EUDAMEDFM-ES0005(Cold)(2400)D EUDAMEDFM-ESN003(2400)(Stiff)D EUDAMEDFM-ES0005(Cold)(2400)(0.27)D EUDAMEDFM-ESN005(Cold)(2400)(0.3)D EUDAMEDFM-ESN002(Crescent)(2400)(Stiff)D EUDAMEDFM-ESN002(2400)(Stiff)D EUDAMEDFM-ES0002(2400)(Soft)D EUDAMEDFM-ESN002(2400)(Soft)D EUDAMEDFM-ES0004(Cold)(2400)D EUDAMEDFM-ESN004(Cold)(2400)(0.3)D EUDAMEDFM-ES0004(Cold)(2400)(0.27)D EUDAMEDFM-ESN006(Cold)(2400)D EUDAMEDFM-ESN003(2400)(Soft)D EUDAMEDFM-ES0005(Cold)(2400)(0.3)D EUDAMED
- Description
- 24mm/ Moderato/ Oval/ Non-Rotation FDA UDI6mm/ Moderato/ Oval/ Rotation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809327351015 EUDAMEDFDA UDI08809327350926 EUDAMEDFDA UDI08809327354306 EUDAMED08809327355846 EUDAMED08809327355181 EUDAMED08809327355228 EUDAMED08809327355358 EUDAMED08809327354511 EUDAMED08809327355167 EUDAMED08809327355440 EUDAMED08809327355198 EUDAMED08809327354542 EUDAMED08809327355235 EUDAMED08809327355457 EUDAMED08809327355839 EUDAMED08809327355822 EUDAMED08809327354290 EUDAMED08809327355310 EUDAMED08809327356485 EUDAMED08809327354535 EUDAMED08809327355853 EUDAMED08809327355327 EUDAMED08809327355389 EUDAMED08809327355426 EUDAMED08809327354283 EUDAMED08809327354528 EUDAMED08809327356492 EUDAMED08809327354481 EUDAMED08809327355419 EUDAMED08809327354320 EUDAMED
- Basic UDI-DI
- 0880932735ESGX EUDAMED
- 510(k) Number
- FDA Product Code
- FDI FDA 510(k)FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 876.4300 FDA 510(k)
- Regulation Number
- 876.4300 FDA 510(k)FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Advisory Committee
- Gastroenterology, Urology 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
Yes
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
No
The ClearGrasp Snare is a flexible endoscopic snare, classified as a Class II medical device. It is designed for use in gastrointestinal and urological procedures to grasp, isolate, and remove tissue or foreign bodies during endoscopic interventions. Its construction allows for precise manipulation within narrow anatomical pathways, ensuring effective retrieval of targeted materials while minimizing trauma to surrounding tissues.
This device is supplied as a single-use, non-sterile instrument and is intended for use in controlled clinical settings such as operating rooms or endoscopy suites. It is compatible with standard endoscopic systems and adheres to MRI safety guidelines for non-ferromagnetic materials. Multiple sizes and configurations are available, as indicated by the listed FEI numbers, to accommodate various procedural requirements. Authorized under FDA 510(k) clearance and MDR compliance, the ClearGrasp Snare is regulated under the classification code 876.4300.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K183289 | Class II | Active |
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Manufacturer
- Manufacturer
- Finemedix Co., Ltd.
Sources (33)
- FDA 510(k) K183289 24 fields · synced Sep 18, 2026
- FDA UDI d284e119-a5ed-4725-8469-c466125b0fee 35 fields · synced May 30, 2026
- FDA UDI 0353d7de-8bad-4ef0-8429-0458c95cb7a4 35 fields · synced May 30, 2026
- EUDAMED e0ba1df3-e950-49cf-b8d1-e01c02f241a9 61 fields · synced Jun 20, 2026
- EUDAMED eccc2366-eaf3-425d-a987-735d46d6c153 61 fields · synced Jul 8, 2026
- EUDAMED 7063203a-f952-4ba9-8307-c32c69c4515f 61 fields · synced Jul 8, 2026
- EUDAMED fd96ee73-fbc7-4592-81df-e6fb94722530 61 fields · synced Jul 8, 2026
- EUDAMED f37e372f-6383-4857-b46a-cf2fb0702236 61 fields · synced Jul 8, 2026
- EUDAMED c0ae3c80-bf2c-42ab-95fd-2d8c3ff39cfe 61 fields · synced Jul 9, 2026
- EUDAMED d3d4adec-6392-4ec2-9bbc-6c495889fa87 61 fields · synced Jul 9, 2026
- EUDAMED 813bd903-be6c-451e-82e7-0644c3f73ea2 61 fields · synced Jul 9, 2026
- EUDAMED 5f7c654f-ca08-4162-a82b-528a2c3b56bf 61 fields · synced Jul 10, 2026
- EUDAMED 9f79fe95-8ec3-4a08-ae8c-4fbd11c4e753 61 fields · synced Jul 10, 2026
- EUDAMED 1f2ad48d-fabe-4e83-982d-db080607f994 61 fields · synced Jul 10, 2026
- EUDAMED 765dbd71-d7e5-4096-a1d7-d61afe33a652 61 fields · synced Jul 10, 2026
- EUDAMED e7f373ad-db3f-4fd4-abe5-92147d2568cc 61 fields · synced Jul 10, 2026
- EUDAMED 505d11de-e1d1-44f2-bf24-ac0af29fa5b9 61 fields · synced Jul 10, 2026
- EUDAMED 39016122-f6e4-42ac-96d1-4dd048bbccf1 61 fields · synced Jul 11, 2026
- EUDAMED 18e13564-fb78-4da7-8325-5047627b47b8 61 fields · synced Jul 11, 2026
- EUDAMED a85f551a-fc89-4690-bc28-1b92d7e7f69a 61 fields · synced Jul 12, 2026
- EUDAMED b8a29c69-ec37-47d8-914a-d22718495dda 61 fields · synced Jul 13, 2026
- EUDAMED b99fc499-6118-4141-92cf-fbbfb98899ff 61 fields · synced Jul 17, 2026
- EUDAMED 60acd284-1d15-4104-b365-5b47031de00d 61 fields · synced Jul 17, 2026
- EUDAMED 419c5233-8b3e-4c32-a036-c83380cb52e5 61 fields · synced Jul 18, 2026
- EUDAMED 78e5cb29-4e76-4d95-ad4f-9e5087bc541a 61 fields · synced Jul 18, 2026
- EUDAMED 3b91bde7-2111-4850-8df7-a1c388e84f2e 61 fields · synced Jul 23, 2026
- EUDAMED c4c3554d-0a07-48ac-98f3-ea1d95a898c1 61 fields · synced Jul 25, 2026
- EUDAMED 44ba6f40-e990-42d3-b584-8804a1f64cbb 61 fields · synced Jul 26, 2026
- EUDAMED 5ffc9cfa-d0b3-49a5-b3ed-452a626b8af1 61 fields · synced Jul 27, 2026
- EUDAMED 50c14583-ae61-441b-8587-475eaa0cc2e3 61 fields · synced Jul 28, 2026
- EUDAMED fc4da6c6-37eb-42a8-9cd1-902a8c1aa52c 61 fields · synced Jul 28, 2026
- EUDAMED 22f016b9-ab4f-426d-8623-dedd5439a596 61 fields · synced Jul 31, 2026
- EUDAMED 48da3d66-2feb-443e-b744-052587deaee0 61 fields · synced Sep 17, 2026