Identity
- Trade Name
- ClearEndoclip FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, short-term FDA UDI
- Device Name
- 11mm/90°/2300mm FDA UDI
- Model / Reference
- FM-CLD11-090(2300) FDA UDI
- Description
- 11mm/90°/2300mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809327353095 FDA UDI
- 510(k) Number
- K200217 FDA UDI
- FDA Product Code
- PKL FDA UDI
- GMDN Term
- Gastrointestinal endoscopic clip, short-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4400 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
MR Conditional FDA UDI
Category: Gastrointestinal endoscopic clip, short-term
ClearEndoclip by Finemedix Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal endoscopic clip, short-term.
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
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- DuraClip(TM) Repositionable Hemostasis Clip — Transmed (China) Co., Ltd. · Class II
- Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
Cleared under the same submission
K200217 also covers:
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 06c1a20b-14ac-4995-a83f-53c1d223ac84 35 fields · synced Jun 1, 2026