510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974775Substantially Equivalent

Single Channel Urological Pressure Gauge, Dual Channel Urological Pressure Gauge

Airtronic Services, Inc., Elk Grove Village IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974775 is the FDA 510(k) clearance record for SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE, a class II device, cleared for Airtronic Services, Inc. on under FDA product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device). FDA records list one 510(k) clearance for Airtronic Services, Inc. As of , FDA records show no recalls naming K974775.

Clearance record

Decision date
Received
(59 days to decision)
Product code
FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Airtronic Services, Inc. 116 N. Lively Blvd., Elk Grove Village IL
510(k) summary
Statement
Third party review
No

Clearances, product code FAP

Trailing 12 months

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

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