Birtcher Sure Clean Instrument System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K930302 ↗

FDA Product Code

GCI

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Abc Laparoscopic Handprobe

  Class II

  FDA 510(k) K910889 Active Cleared 29 Aug 1991

• Birtcher Laparoscope and Accessories

  Class II

  FDA 510(k) K932987 Active Cleared 25 Apr 1994

• Birtcher Swivel Grip Laparoscopic Probes & Access.

  Class II

  FDA 510(k) K932779 Active Cleared 21 Mar 1995

• Birtcher Bronchus & Lung Clamp (Gs-1620 & Gs-1600)

  Class II

  FDA 510(k) K930887 Active Cleared 25 Apr 1994

• Birtcher Magnetic Retriever (Gs-3100)

  Class II

  FDA 510(k) K931654 Active Cleared 25 Apr 1994

• Laparoscopic 5MM ABC Probe, Modification

  Class II

  FDA 510(k) K925903 Active Cleared 30 Dec 1992

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