Chakoff Endoscopy

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

510(k) Number

K932627 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Chakoff Endoscopy (Fiber Optic Light Source Routine)

  Class II

  FDA 510(k) K950748 Active Cleared 6 Mar 1995

• Xenon Light Source Illuminator

  Class II

  FDA 510(k) K932631 Active Cleared 16 Nov 1993

• Chakoff Endoscopy (Camera Television Endoscopic Without Audio

  Class II

  FDA 510(k) K950753 Active Cleared 15 May 1995

• Chakoff Endoscopy

  Class II

  FDA 510(k) K945420 Active Cleared 8 Dec 1994

• Chakoff Endoscopy (Endoscope and/or Accessories)

  Class II

  FDA 510(k) K950745 Active Cleared 6 Mar 1995

• Chakoff Endoscopy Laparoscopic Instrumentation

  Class II

  FDA 510(k) K932632 Active Cleared 21 Jun 1994

See all devices from Stephen Chakoff, Inc. →

• What is the Chakoff Endoscopy device used for?

  The Chakoff Endoscopy is a medical device intended for use in endoscopic procedures specifically within gastroenterology and urology applications. It is classified under product code GCJ and manufactured by Stephen Chakoff, Inc.

• What is the regulatory status of the Chakoff Endoscopy device?

  The Chakoff Endoscopy device received FDA 510(k) clearance with number K932627 on February 4, 1994. It is classified as a Class 2 device and was determined to be substantially equivalent through the traditional clearance process.

• Is the Chakoff Endoscopy device sterile or single-use?

  The device data does not provide information regarding sterility status or whether the Chakoff Endoscopy is designed for single-use or reuse. This information would need to be obtained directly from the manufacturer or product documentation.

• What advisory committees reviewed the Chakoff Endoscopy device?

  The Chakoff Endoscopy device was reviewed by the Gastroenterology, Urology (GU) advisory committee, with the review advisory committee designated as SU (Surgical Devices). This indicates specialized review for its intended applications.