510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945131Substantially Equivalent

Imagyn Intrauterine Insemination Device

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

K945131 is the FDA 510(k) clearance record for IMAGYN INTRAUTERINE INSEMINATION DEVICE, a class II device, cleared for Imagyn Medical, Inc. on under FDA product code HDR (Cap, Cervical). FDA records list 19 510(k) clearances for Imagyn Medical, Inc., from to . As of , FDA records show no recalls naming K945131.

Clearance record

Decision date
Received
(208 days to decision)
Product code
HDR Cap, Cervical
Regulation
21 CFR 884.5250
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 HDR

Trailing 12 months

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

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