Fg-36UX Fiber Ultrasound Gastroscope

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K021276 ↗

FDA Product Code

ODG

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K951198 Active Cleared 30 May 1995

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  Class II

  FDA 510(k) K013640 Active Cleared 4 Feb 2002

• Fs-38X, Fiber Sigmoidoscope

  Class II

  FDA 510(k) K951572 Active Cleared 27 Jun 1995

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  FDA 510(k) K961570 Active Cleared 24 Jun 1996

• Fcp-9P, Fiber Choledochoscope

  Class II

  FDA 510(k) K953286 Active Cleared 3 Nov 1995

• Fi-10P

  Class I

  FDA 510(k) K951195 Active Cleared 6 Apr 1995

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