Skip to content

Scotts Surgical Retractor and Elastic

by Lone Star Medical Products

510(k) K791665

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK791665 Date19 Sep 1979ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-3278-2018 FDA Class II initiated 4 Sep 2018

    There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GAD
FDA applicant
Lone Star Medical Products, Inc.
Device Class
Class I
Regulation
21 CFR Part 878.4800
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Lone Star Medical Products