Identity
- Trade Name
- Instinct FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI
- Device Name
- Instinct Endoscopic Hemoclip FDA UDI
- Model / Reference
- G18344 FDA UDI
- Description
- Instinct Endoscopic Hemoclip FDA UDI
Identifiers
- Catalog Number
- INSC-7-230-20-S FDA UDI
- Primary DI / UDI-DI
- 00827002183445 FDA UDI
- 510(k) Number
- K132809 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
Yes
FDA UDI
MR Conditional FDA UDI
Category: Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Instinct by Cook Incorporated — 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
- 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
- RETENTIA Hemoclip — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · 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
K132809 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
- Cook Incorporated
Sources (1)
- FDA UDI 39eddcc4-8f36-4ced-bb2a-76ace74fd3cb 37 fields · synced Jun 8, 2026