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nxt™ Bipolar Forceps Bayonet non-stick silver

by adeor Medical AG 14 variants

nxt™ Bipolar Forceps Bayonet non-stick silver (BIP-S094US-SU) is a Class II device made by adeor Medical AG, cleared under FDA 510(k) K191847 on 22 May 2020 and listed in FDA GUDID since 11 Aug 2022 (UDI-DI 04251388940693), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K191847

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04251388940693 UDI-DI Date11 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191847 Date22 May 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191847 decided 22 May 2020 Active
  • FDA GUDID UDI-DI 04251388940693 listed 11 Aug 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191847
  2. Listed FDA GUDID 04251388940693

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
nxt™ Bipolar Forceps
Generic name
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Model / Ref / Catalog
Bayonet non-stick silver, BIP-S094US-SU
Primary DI / UDI-DI
04251388940693
510(k) Number
FDA product code
GEI
GMDN term
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Other devices from adeor Medical AG

See all devices from adeor Medical AG →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)