Identity
- Trade Name
- remOVE DC Impulse FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip cutter generator FDA UDI
- Device Name
- The remOVE DC Impulse Generator is part of the remOVE System and is a medical electrical device for fragmentation of OTSC and FTRD clips made by Ovesco Endoscopy AG for the digestive tract • design ensures a direct pulse only when sufficient contact with a segment of the clip is established • required accessories for operating the remOVE DC Impulse are: DC Impulse generator | foot-activated switch with connector cable | power cord | DC cord in order to connect the DC Cutter (part of remOVE DC Cutter Set) • can only be used in combination with remOVE DC Cutter Set FDA UDI
- Model / Reference
- 400.01 FDA UDI
- Description
- The remOVE DC Impulse Generator is part of the remOVE System and is a medical electrical device for fragmentation of OTSC and FTRD clips made by Ovesco Endoscopy AG for the digestive tract • design ensures a direct pulse only when sufficient contact with a segment of the clip is established • required accessories for operating the remOVE DC Impulse are: DC Impulse generator | foot-activated switch with connector cable | power cord | DC cord in order to connect the DC Cutter (part of remOVE DC Cutter Set) • can only be used in combination with remOVE DC Cutter Set FDA UDI
Identifiers
- Catalog Number
- 400.01 FDA UDI
- Primary DI / UDI-DI
- 04260206310563 FDA UDI
- 510(k) Number
- DEN160014 FDA UDI
- FDA Product Code
- QAG FDA UDI
- GMDN Term
- Gastrointestinal endoscopic clip cutter generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gastrointestinal endoscopic clip cutter generator
remOVE DC Impulse by Ovesco Endoscopy AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
DEN160014 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
- Ovesco Endoscopy AG
Sources (1)
- FDA UDI 3990d312-7077-44fd-9c10-6d9bb2448b47 36 fields · synced May 30, 2026