Cleared Traditional

MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS

K063223 · CooperSurgical, Inc. · Obstetrics & Gynecology
Jan 2008
Decision
456d
Days
Class 2
Risk

About This 510(k) Submission

K063223 is an FDA 510(k) clearance for the MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS, a Diaphragm, Contraceptive (and Accessories) (Class II — Special Controls, product code HDW), submitted by CooperSurgical, Inc. (Shelton, US). The FDA issued a Cleared decision on January 23, 2008, 456 days after receiving the submission on October 24, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5350.

Submission Details

510(k) Number K063223 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2006
Decision Date January 23, 2008
Days to Decision 456 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HDW — Diaphragm, Contraceptive (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5350