510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801757Substantially Equivalent

Mmi/gaeltec Catheter Tip Press. Transdu

Medical Measurements, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801757 is the FDA 510(k) clearance record for MMI/GAELTEC CATHETER TIP PRESS. TRANSDU, a class II device, cleared for Medical Measurements, Inc. on under FDA product code FES (Recorder, External, Pressure, Amplifier & Transducer). FDA records list 8 510(k) clearances for Medical Measurements, Inc., from to . As of , FDA records show no recalls naming K801757.

Clearance record

Decision date
Received
(30 days to decision)
Product code
FES Recorder, External, Pressure, Amplifier & Transducer
Regulation
21 CFR 876.1725
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medical Measurements, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FES

Trailing 12 months

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

FDA records show no clearances under product code FES in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FES, 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