Identity
- Trade Name
- ClearGrasp Snare FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- 10mm/ Soft/ Oval/ Rotation FDA UDI
- Model / Reference
- FM-ES0004(2400)(Soft)A FDA UDI
- Description
- 10mm/ Soft/ Oval/ Rotation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809327351701 FDA UDI
- 510(k) Number
- K183289 FDA UDI
- FDA Product Code
- FDI FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic electrosurgical electrode, monopolar, single-use
ClearGrasp Snare by Finemedix Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183289 also covers:
- ClearGrasp Snare — Finemedix Co., Ltd.
- ClearGrasp Snare — Finemedix Co., Ltd.
- ClearGrasp Snare — Finemedix Co., Ltd.
- ClearGrasp Snare — Finemedix Co., Ltd.
- ClearGrasp Snare — Finemedix Co., Ltd.
- ClearGrasp Snare — Finemedix Co., Ltd.
- ClearGrasp Snare — Finemedix Co., Ltd.
- ClearGrasp Snare — Finemedix Co., Ltd.
- ClearGrasp Snare — Finemedix Co., Ltd.
- ClearGrasp Snare — Finemedix Co., Ltd.
- ClearGrasp Snare — Finemedix Co., Ltd.
- ClearGrasp Snare — Finemedix Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Finemedix Co., Ltd.
Sources (1)
- FDA UDI 39e2723b-0eaf-4ef9-b567-6ad44bf13df6 35 fields · synced Jun 8, 2026