Laparoscopic Trocar Starter Scalpel

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

510(k) Number

K936154 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

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• What is the primary function of the Laparoscopic Trocar Starter Scalpel?

  This instrument is specifically designed for use in laparoscopic procedures. It serves as a starter tool to create the initial incision necessary for the subsequent insertion of a trocar.

• In which medical fields is this device intended for use?

  The device is intended for use within the clinical fields of gastroenterology and urology, as indicated by its classification under the relevant advisory committees.

• What is the regulatory status of this surgical instrument?

  The Laparoscopic Trocar Starter Scalpel is identified by FDA 510(k) number K936154. It was cleared through a traditional 510(k) submission process and determined to be substantially equivalent to existing devices.