The Scott Dialmenzensert

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K810915 ↗

FDA Product Code

KOA

FDA applicant

Lone Star Medical Products, Inc.

Device Class

Class I

Regulation

21 CFR Part 876.4730

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 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

• Surgical Isolation Barrier System

  Not classified

  FDA 510(k) K831531 Active Cleared 5 Jun 1984

• P-3 Closing Instrument

  Not classified

  FDA 510(k) K850041 Active Cleared 21 Feb 1985