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Valleylab VLFT10FXGENRFB

by Covidien LP

Valleylab VLFT10FXGENRFB is a Class II device made by Covidien LP, cleared under FDA 510(k) K241085 on 12 Jul 2024 and listed in FDA GUDID since 12 May 2025 (UDI-DI 10884521851566), 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) K241085

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 Number10884521851566 UDI-DI Date12 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241085 Date12 Jul 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241085 decided 12 Jul 2024 Active
  • FDA GUDID UDI-DI 10884521851566 listed 12 May 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241085
  2. Listed FDA GUDID 10884521851566

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  • Withdrawn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
Electrosurgical system generator
Model / reference
VLFT10FXGENRFB
Primary DI / UDI-DI
10884521851566
510(k) Number
FDA product code
OCL, GEI
GMDN term
Electrosurgical system generator
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

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See all devices from Covidien LP →

Properties

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