510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K811083Substantially Equivalent

Esophageal Motility Probe

Konigsberg Instruments, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811083 is the FDA 510(k) clearance record for ESOPHAGEAL MOTILITY PROBE, a class I device, cleared for Konigsberg Instruments, Inc. on under FDA product code FFT (Electrode, Ph, Stomach). FDA records list 3 510(k) clearances for Konigsberg Instruments, Inc., from to . As of , FDA records show no recalls naming K811083.

Clearance record

Decision date
Received
(114 days to decision)
Product code
FFT Electrode, Ph, Stomach
Regulation
21 CFR 876.1400
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Konigsberg Instruments, Inc. 4221 Richmond Rd., NW, Walker MI
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