510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940425Substantially Equivalent

Imagyn Medical Inflation Device with Non-Invasive Pressure Tubing

Imagyn Medical, Inc., Laguna Niguel CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940425 is the FDA 510(k) clearance record for IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING, a class II device, cleared for Imagyn Medical, Inc. on under FDA product code MAV (Syringe, Balloon Inflation). FDA records list 19 510(k) clearances for Imagyn Medical, Inc., from to . As of , FDA records show no recalls naming K940425.

Clearance record

Decision date
Received
(182 days to decision)
Product code
MAV Syringe, Balloon Inflation
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Imagyn Medical, Inc. 27651 La Paz Rd., Laguna Niguel CA
510(k) summary
Summary
Third party review
No

Clearances, product code MAV

Trailing 12 months
1 clearance under product code MAV in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MAV, 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 20261
October 20260