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Arm Monopolar scissors B-1304

by Dex Surgical

Arm Monopolar scissors B-1304 is a Class II device made by Dex Surgical, cleared under FDA 510(k) K191878 on 29 Jan 2021 and listed in FDA GUDID since 6 May 2022 (UDI-DI 03665772000077), 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) K191878

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 Number03665772000077 UDI-DI Date6 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191878 Date29 Jan 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191878 decided 29 Jan 2021 Active
  • FDA GUDID UDI-DI 03665772000077 listed 6 May 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191878
  2. Listed FDA GUDID 03665772000077

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Arm Monopolar scissors
Generic name
Endoscopic electromechanical surgical system
Model / reference
B-1304
Primary DI / UDI-DI
03665772000077
510(k) Number
FDA product code
GEI
GMDN term
Endoscopic electromechanical surgical system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endoscopic electromechanical surgical system

Cleared under the same submission (K191878)

and 5 more cleared under K191878

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Other devices from Dex Surgical

See all devices from Dex Surgical →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)