← Back to catalogue
Instinct Plus Endoscopic Clipping Device
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref INSC-P-7-230-S510(k) K212323
Identity
- Trade Name
- Instinct Plus Endoscopic Clipping Device EUDAMEDInstinct Plus® Endoscopic Clipping Device EUDAMEDInstinct FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI
- Device Name
- Instinct Plus Endoscopic Clipping Device EUDAMEDFDA UDI
- Model / Reference
- INSC-P-7-230-S EUDAMEDG58010 FDA UDI
- Description
- Instinct Plus Endoscopic Clipping Device FDA UDI
Identifiers
- Catalog Number
- INSC-P-7-230-S FDA UDI
- Primary DI / UDI-DI
- 00827002580107 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002WCM00000000020ME EUDAMED
- FDA Product Code
- PKL FDA UDI
- EMDN Code
- G030202 DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS EUDAMED
- GMDN Term
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Instinct Plus Endoscopic Clipping Device by Wilson-Cook Medical, Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192697 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K212323 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K023903 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0827002WCM00000000020ME | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
- EUDAMED SRN
- US-MF-000002658
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (4)
- EUDAMED cbab0f85-9264-49fc-940e-1b85c896f955 85 fields · synced Jun 19, 2026
- FDA UDI f02821be-22b0-43ba-8891-55803cd3d11c 36 fields · synced May 30, 2026
- EUDAMED 479be145-a0f2-49c8-b267-d9af41169d69 61 fields · synced Jun 19, 2026
- FDA 510(k) K192697 1 fields · synced May 18, 2026