Identity
- Trade Name
- Aquamantys ® FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- BIPOLAR SEALER 23-121-1 AQM EVS NEURO FDA UDI
- Model / Reference
- 23-121-1 FDA UDI
- Description
- BIPOLAR SEALER 23-121-1 AQM EVS NEURO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169456204 FDA UDI
- 510(k) Number
- K132974 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Aquamantys ® by Medtronic Navigation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, single-use.
- nxt™ Bipolar Forceps — adeor Medical AG · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Symmetry Olsen — Olsen Medical · Class II
- AESCULAP — AESCULAP, INC. · Class II
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Symmetry Olsen — Olsen Medical · Class II
Cleared under the same submission
K132974 also covers:
- Aquamantys — MEDTRONIC NAVIGATION, INC.
- Aquamantys — MEDTRONIC NAVIGATION, INC.
- Aquamantys — MEDTRONIC NAVIGATION, INC.
- Aquamantys — MEDTRONIC NAVIGATION, INC.
- Aquamantys ® — MEDTRONIC NAVIGATION, INC.
- Aquamantys(TM) — MEDTRONIC NAVIGATION, INC.
- Aquamantys(TM) — MEDTRONIC NAVIGATION, INC.
- Aquamantys(TM) — MEDTRONIC NAVIGATION, INC.
- Aquamantys(TM) — MEDTRONIC NAVIGATION, INC.
- Aquamantys™ — MEDTRONIC NAVIGATION, INC.
- Aquamantys™ — MEDTRONIC NAVIGATION, INC.
- Aquamantys™ — MEDTRONIC NAVIGATION, INC.
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
- Medtronic Navigation, Inc.
Sources (1)
- FDA UDI f72ecdbc-5d6e-49ba-8988-0ed618f9c140 36 fields · synced May 30, 2026