510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963580Substantially Equivalent

Imagyn Falloposcopy System

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

K963580 is the FDA 510(k) clearance record for IMAGYN FALLOPOSCOPY SYSTEM, a class II device, cleared for Imagyn Medical, Inc. on under FDA product code MKO (Falloposcope). FDA records list 19 510(k) clearances for Imagyn Medical, Inc., from to . As of , FDA records show no recalls naming K963580.

Clearance record

Decision date
Received
(147 days to decision)
Product code
MKO Falloposcope
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Imagyn Medical, Inc. 27651 La Paz Rd., Laguna Niguel CA
510(k) summary
Summary
Third party review
No

Clearances, product code MKO

Trailing 12 months

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

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