MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS— 510(k) K063223
Substantially EquivalentCooperSurgical, Inc.
FDA 510(k) clearance K063223 for MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS, Substantially Equivalent on 2008-01-23. Applicant: CooperSurgical, Inc.. Device class: 2.
Clearance details
- Applicant
- CooperSurgical, Inc.
- Product code
- Code HDW
- Device class
- Class 2
- Regulation
- 21 CFR 884.5350
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
Recent devices under product code HDW
view allMore clearances from CooperSurgical, Inc.
view allRecalls naming K063223
K-number listed on FDA's recall record- Z-1054-2016 — Milex Arcing Diaphragm Size 95; Model Number: MXWS95
- Z-1814-2015 — MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
- Z-1018-2013 — Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063223.
Data sourced from openFDA. This site is unofficial and independent of the FDA.