510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950087Substantially Equivalent

Lot 440

Medical Instruments Corporation Mic AG, Solothurn, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950087 is the FDA 510(k) clearance record for LOT 440, a class I device, cleared for Medical Instruments Corporation Mic AG on under FDA product code FFT (Electrode, Ph, Stomach). FDA records list 2 510(k) clearances for Medical Instruments Corporation Mic AG, from to . As of , FDA records show no recalls naming K950087.

Clearance record

Decision date
Received
(392 days to decision)
Product code
FFT Electrode, Ph, Stomach
Regulation
21 CFR 876.1400
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Medical Instruments Corporation Mic AG Friedhofplatz 16, Pob 706, Solothurn, CH
510(k) summary
Statement
Third party review
No

Clearances, product code FFT

Trailing 12 months

FDA records hold no clearances under product code FFT in the trailing twelve months.

FDA records show no clearances under product code FFT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FFT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260