Identity
- Trade Name
- remOVE DC Cutter Set FDA UDI
- Generic Name
- Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
- Device Name
- The remOVE DC Cutter Set 14 is part of the remOVE System and consists of the following products: remOVE DC Cutter is a bipolar endoscopic direct current (DC) instrument for fragmentation of OTSC and FTRD clips in the digestive tract • consists of an insulated conducting wire with an exposed tip • intended to conduct the direct current (DC) supplied by the remOVE DC Impulse to a previously implanted clip • separation of the clip through resistive heating • remOVE DC Cutter is designed to be used only with the remOVE DC Impulse and flexible endoscopes | remOVE SecureCap 14 is an elastic and transparent retrieval cap for safe extraction of the clip fragments | remOVE Grasper is a grasping forceps for retrieval of clip fragments into the remOVE SecureCap • for removal of these fragments out of the GI tract FDA UDI
- Model / Reference
- 14 FDA UDI
- Description
- The remOVE DC Cutter Set 14 is part of the remOVE System and consists of the following products: remOVE DC Cutter is a bipolar endoscopic direct current (DC) instrument for fragmentation of OTSC and FTRD clips in the digestive tract • consists of an insulated conducting wire with an exposed tip • intended to conduct the direct current (DC) supplied by the remOVE DC Impulse to a previously implanted clip • separation of the clip through resistive heating • remOVE DC Cutter is designed to be used only with the remOVE DC Impulse and flexible endoscopes | remOVE SecureCap 14 is an elastic and transparent retrieval cap for safe extraction of the clip fragments | remOVE Grasper is a grasping forceps for retrieval of clip fragments into the remOVE SecureCap • for removal of these fragments out of the GI tract FDA UDI
Identifiers
- Catalog Number
- 400.02.02s FDA UDI
- Primary DI / UDI-DI
- 04260206310921 FDA UDI
- 510(k) Number
- DEN160014 FDA UDI
- FDA Product Code
- QAG FDA UDI
- GMDN Term
- Flexible endoscopic tissue manipulation forceps, single-use 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
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
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: Flexible endoscopic tissue manipulation forceps, single-useEndoscope tissue removal cap, single-useGastrointestinal endoscopic clip cutter
remOVE DC Cutter Set by Ovesco Endoscopy AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal endoscopic clip cutter.
- remOVE DC Cutter Set — Ovesco Endoscopy AG · Class II
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 0570ec45-79ec-420d-a36e-149551c18309 37 fields · synced May 31, 2026