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Versajet 66800045

by Smith & Nephew Medical, Ltd.

Versajet 66800045 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 00040565124780), 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 Number00040565124780 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 00040565124780 listed 20 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K143115
  2. Listed FDA GUDID 00040565124780

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  • Withdrawn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 handpiece, single-use
Model / Ref / Catalog
66800045
Primary DI / UDI-DI
00040565124780
510(k) Number
FDA product code
FQH
GMDN term
Water jet knife system handpiece, single-use
Device class
Class II
Regulation number
880.5475
GUDID distribution status
In Commercial Distribution

Related devices

Category: Water jet knife system handpiece, single-use

Cleared under the same submission (K143115)

and 6 more cleared under K143115

Similar devices in this category

Other devices filed under Water jet knife system handpiece, single-use.

Other devices from Smith & Nephew Medical, Ltd.

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

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)