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Valleylab Force Argon II-8

by Covidien LP

Valleylab Force Argon II-8 is a medical device (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Covidien LP, cleared under FDA 510(k) K964636 on 11 Mar 1997 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884524002569), 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) K964636

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 Number10884524002569 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK964636 Date11 Mar 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K964636 decided 11 Mar 1997 Active
  • FDA GUDID UDI-DI 10884524002569 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K964636
  2. Listed FDA GUDID 10884524002569

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Valleylab
Generic name
Inert gas-enhanced electrosurgical system generator
Model / reference
Force Argon II-8
Primary DI / UDI-DI
10884524002569
510(k) Number
FDA product code
GEI
GMDN term
Inert gas-enhanced electrosurgical system generator
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES).

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  • Shiley 110870

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See all devices from Covidien LP →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)