Identity
- Trade Name
- Assurance FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable FDA UDI
- Device Name
- The Assurance Clip - 13mm 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
- 00711883 FDA UDI
- Description
- The Assurance Clip - 13mm 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
- 00711883 FDA UDI
- Primary DI / UDI-DI
- 00724995190521 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.
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- 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 |
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Manufacturer
- Manufacturer
- US Endoscopy
Sources (1)
- FDA UDI 4ef6f63c-d1f3-4a9d-a5f5-800c06be6936 36 fields · synced Jun 6, 2026