Identity
- Trade Name
- Assurance FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI
- Device Name
- The Assurance Clip - 11 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purpose of mechanical pressure treatment of bleeding of small arteries and pulsation. FDA UDI
- Model / Reference
- 00711926 FDA UDI
- Description
- The Assurance Clip - 11 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purpose of mechanical pressure treatment of bleeding of small arteries and pulsation. FDA UDI
Identifiers
- Catalog Number
- 00711926 FDA UDI
- Primary DI / UDI-DI
- 00724995220686 FDA UDI
- 510(k) Number
- K172727 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
Assurance by US Endoscopy — 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
- 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
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
- US Endoscopy
Sources (1)
- FDA UDI 58707e13-a631-410d-bd16-6ff3e9149805 36 fields · synced May 30, 2026