Identity
- Trade Name
- ASCENDO submucosal lifting agent FDA UDI
- Generic Name
- Submucosal lift solution FDA UDI
- Model / Reference
- 00712935 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00724995231866 FDA UDI
- 510(k) Number
- K241591 FDA UDI
- FDA Product Code
- PLL FDA UDI
- GMDN Term
- Submucosal lift solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- 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
No
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
No
FDA UDI
Category: Submucosal lift solution
ASCENDO submucosal lifting agent by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Submucosal lift solution.
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- Eleview — Cosmo Technologies, Ltd. · Class II
- Blue Eye — THE STANDARD CO., LTD. · Class II
Cleared under the same submission
K241591 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 8f357892-36c2-4d1d-ae96-0dfbed0ca164 33 fields · synced Jun 8, 2026