Surgical Isolation Barrier System

No FDA recalls found in the data synced 12 Oct 2026.

510(k) Number

K831531 ↗

FDA applicant

Lone Star Medical Products, Inc.

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• The Scott Dialmenzensert

  Class I

  FDA 510(k) K810915 Active Cleared 8 May 1981

• The Inquinal Resorvoir Inserter

  Class I

  FDA 510(k) K802983 Active Cleared 30 Dec 1980

• Urethal Cutter Clamp

  Class I

  FDA 510(k) K820015 Active Cleared 22 Feb 1982

• Scotts Surgical Retractor and Elastic

  Class I

  FDA 510(k) K791665 Active Cleared 19 Sep 1979

• P-3 Closing Instrument

  Not classified

  FDA 510(k) K850041 Active Cleared 21 Feb 1985