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nxt™ Bipolar Forceps

FDA UDI

Class II (US FDA UDI)

by adeor Medical AG

Identity

Trade Name
nxt™ Bipolar Forceps FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Model / Reference
Bayonet non-stick silver FDA UDI

Identifiers

Catalog Number
BIP-S094US-SU FDA UDI
Primary DI / UDI-DI
04251388940693 FDA UDI
510(k) Number
K191847 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

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, single-use.

Cleared under the same submission

K191847 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
adeor Medical AG

Sources (1)

  • FDA UDI eed26682-c203-4846-8c62-143494de423b 34 fields · synced Jun 1, 2026