Identity
- Trade Name
- ESD AqaNife FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes • precise marking of tissue • stable position of the needle • ceramic socket as stopper and protector • opening in the ceramic socket for flushing and re-injection • for thin tissue (needle length of 1.5 mm) FDA UDI
- Model / Reference
- 1.5 mm FDA UDI
- Description
- The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes • precise marking of tissue • stable position of the needle • ceramic socket as stopper and protector • opening in the ceramic socket for flushing and re-injection • for thin tissue (needle length of 1.5 mm) FDA UDI
Identifiers
- Catalog Number
- 200.53.01 FDA UDI
- Primary DI / UDI-DI
- 04260206310389 FDA UDI
- 510(k) Number
- K141790 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
ESD AqaNife by Ovesco Endoscopy AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K141790 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 b154467a-fb39-4700-b074-ad7e374480cf 38 fields · synced May 31, 2026