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Versajet 66800039

by Smith & Nephew Medical, Ltd.

Versajet 66800039 is a Class II device made by Smith & Nephew Medical, Ltd., cleared under FDA 510(k) K143115 on 15 Jul 2015 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00040565124759), 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) K143115

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 Number00040565124759 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143115 Date15 Jul 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143115 decided 15 Jul 2015 Active
  • FDA GUDID UDI-DI 00040565124759 listed 20 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K143115
  2. Listed FDA GUDID 00040565124759

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Versajet
Generic name
Water jet knife system generator
Model / Ref / Catalog
66800039
Primary DI / UDI-DI
00040565124759
510(k) Number
FDA product code
FQH
GMDN term
Water jet knife system generator
Device class
Class II
Regulation number
880.5475
GUDID distribution status
In Commercial Distribution

Related devices

Category: Water jet knife system generator

Cleared under the same submission (K143115)

and 6 more cleared under K143115

Similar devices

Other devices filed under FDA product code FQH (Lavage, Jet).

Other devices from Smith & Nephew Medical, Ltd.

See all devices from Smith & Nephew Medical, Ltd. →

Properties

  • Serial number
Other properties (14, all answered No)