Identity
- Trade Name
- EndoClot SIS FDA UDI
- Generic Name
- Submucosal lift solution FDA UDI
- Device Name
- EndoClot Submucosal Injection System FDA UDI
- Model / Reference
- SIS-15-01 FDA UDI
- Description
- EndoClot Submucosal Injection System FDA UDI
Identifiers
- Catalog Number
- SIS-15-01 FDA UDI
- Primary DI / UDI-DI
- 16972011720257 FDA UDI
- 510(k) Number
- K191254 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Submucosal lift solution
EndoClot SIS by EndoClot Plus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Submucosal lift solution.
- ORISE™ Gel — Boston Scientific · Class II
- ORISE™ Gel — Boston Scientific · Class II
- ORISE™ Gel — Boston Scientific · Class II
- ORISE™ Gel — Boston Scientific · Class II
- Eleview 5mL — Cosmo Technologies, Ltd. · Class II
- Eleview — Cosmo Technologies, Ltd. · Class II
- ASCENDO submucosal lifting agent — US Endoscopy · Class II
- Ascendo — US Endoscopy · Class II
Cleared under the same submission
K191254 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
- EndoClot Plus, Inc.
Sources (1)
- FDA UDI 5cf4b479-a559-4193-81c7-f9871ce0b06d 35 fields · synced Jun 6, 2026