Identity
- Trade Name
- Hemoclip FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI
- Model / Reference
- FTL-HC-16-230-O FDA UDI
Identifiers
- Catalog Number
- MMC-230-16 FDA UDI
- Primary DI / UDI-DI
- 06936603226674 FDA UDI
- 510(k) Number
- K230004 FDA UDI
- FDA Product Code
- PKL FDA UDI
- GMDN Term
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Hemoclip by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal endoscopic clip, long-term, non-bioabsorbable.
- OTSC System Set — Ovesco Endoscopy USA · Class II
- OTSC System Set — Ovesco Endoscopy USA · Class II
- Instinct — COOK INCORPORATED · Class II
- S.T.A.R(TM) Disposable Hemostatic Closure Clip Device — Micro-Tech (Nanjing) Co., Ltd. · Class II
- OTSC System Set — Ovesco Endoscopy AG · Class II
- OTSC System Set — Ovesco Endoscopy AG · Class II
- OTSC System Set — Ovesco Endoscopy USA · Class II
- S.T.A.R(TM) Disposable Hemostatic Closure Clip Device — Micro-Tech (Nanjing) Co., Ltd. · Class II
Cleared under the same submission
K230004 also covers:
- RETENTIA Hemoclip — Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- RETENTIA Hemoclip — Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- RETENTIA Hemoclip — Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- RETENTIA Hemoclip — Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- RETENTIA Hemoclip — Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- RETENTIA Hemoclip — Yangzhou Fartley Medical Instrument Technology 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
Sources (1)
- FDA UDI a8952262-39ff-45fc-a0d5-157a52b9f007 34 fields · synced May 30, 2026