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Renasys 66800193

by Smith & Nephew Medical, Ltd.

Renasys 66800193 is a Class II device made by Smith & Nephew Medical, Ltd., cleared under FDA 510(k) K143115 on 15 Jul 2015 (1 earlier submission) and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00040565123943), 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

1 ongoing

Recall on shared 510(k) K142979; other models may be affected

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00040565123943 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· +1 more in the status table
  • FDA GUDID UDI-DI 00040565123943 listed 20 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2848-2016 FDA Class II initiated 21 Jul 2016 on shared 510(k) K142979

    Sterility seal integrity failures on the Renasys Sterile Transparent Film

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K142979
  2. Cleared FDA 510(k) K143115
  3. Recall initiated FDA recalls Z-2848-2016
  4. Listed FDA GUDID 00040565123943

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Renasys
Generic name
Water jet knife system generator
Model / Ref / Catalog
66800193
Primary DI / UDI-DI
00040565123943
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
MRI safety
MR Unsafe

Related devices

Category: Water jet knife system generator

Cleared under the same submission (K142979)

and 8 more cleared under K142979

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

  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)