Identity
- Trade Name
- nxt™ Bipolar Forceps FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Model / Reference
- Atlas Choice™ Low Profile Ultra Non-Stick Microbipolar Forceps - Bayonet - Black FDA UDI
Identifiers
- Catalog Number
- BIP-ATMI-03-IR-RU FDA UDI
- Primary DI / UDI-DI
- 04251388960660 FDA UDI
- 510(k) Number
- K191847 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
nxt™ Bipolar Forceps by adeor Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.
- AESCULAP — AESCULAP, INC. · Class II
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C. · Class II
- STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C. · Class II
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- CODMAN® — Integra LifeSciences Production Corporation · Class II
Cleared under the same submission
K191847 also covers:
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
- nxt™ Bipolar Forceps — adeor Medical AG
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
- adeor Medical AG
Sources (1)
- FDA UDI 434a9b2d-a8ac-4541-bdb6-a8b4f731a27b 34 fields · synced May 30, 2026