Identity
- Trade Name
- Key Surgical Hemostasis Clips FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, short-term FDA UDI
- Device Name
- Hemostasis Clip, Rotatable, Single-Use, Coated, 16mm (Opening) W FDA UDI
- Model / Reference
- EN10400A.16 FDA UDI
- Description
- Hemostasis Clip, Rotatable, Single-Use, Coated, 16mm (Opening) W FDA UDI
Identifiers
- Catalog Number
- EN10400A16 FDA UDI
- Primary DI / UDI-DI
- 00849771039204 FDA UDI
- 510(k) Number
- K172727 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
- Not 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Key Surgical Hemostasis Clips by Key Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K172727 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Key Surgical, LLC
Sources (1)
- FDA UDI eed7c0aa-a249-4d4d-89b0-1e806b338416 39 fields · synced Jun 8, 2026