Cabot Medical Optima Hand Instruments

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K932976 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Cabot Medical Optima Hand Instruments

  Class II

  FDA 510(k) K932977 Active Cleared 7 Sep 1993

• Cabot Medical Surgiflex(R) Suction-Irrigation Prob

  Class II

  FDA 510(k) K932626 Active Cleared 8 Jun 1994

• Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic Sheaths

  Class II

  FDA 510(k) K951972 Active Cleared 21 Jul 1995

• Cabot Disposable 10mm Suction Device

  Class II

  FDA 510(k) K924048 Active Cleared 22 Jan 1993

• Pleatman Sac Specimen Container

  Class II

  FDA 510(k) K923945 Active Cleared 5 Feb 1993

• Corson and Nezhat Suction/Irrigation Probes

  Class II

  FDA 510(k) K935786 Active Cleared 19 May 1994

See all devices from Cabot Medical Corp. →

• What are Cabot Medical Optima Hand Instruments used for?

  These instruments are designed for use in general and plastic surgery applications. They are medical devices specifically created for surgical procedures in these fields.

• Are the Cabot Medical Optima Hand Instruments single-use or reusable?

  The instruments can be either single-use or reusable as specified by the manufacturer. The usage instructions would indicate which applies to specific instruments within this product line.

• What regulatory clearance do these instruments have?

  The Cabot Medical Optima Hand Instruments have FDA 510(k) clearance with product code GCJ. They were determined to be substantially equivalent to predicate devices through the traditional clearance process.

• Where are these instruments manufactured?

  The Cabot Medical Optima Hand Instruments are manufactured in Langhorne, Pennsylvania at the facility located at 2021 Cabot Blvd. W.