510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K063223Substantially Equivalent

Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms, Wideseal Diaphragms

CooperSurgical, Inc., Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063223 is the FDA 510(k) clearance record for MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS, a class II device, cleared for CooperSurgical, Inc. on under FDA product code HDW (Diaphragm, Contraceptive (And Accessories)). FDA records list 103 510(k) clearances for CooperSurgical, Inc., from to . As of , FDA records show 3 recalls naming K063223.

Clearance record

Decision date
Received
(456 days to decision)
Product code
HDW Diaphragm, Contraceptive (And Accessories)
Regulation
21 CFR 884.5350
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
CooperSurgical, Inc. 543 Long Hill Ave., Shelton CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HDW

Trailing 12 months

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

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