PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE— 510(k) K012277

Substantially Equivalent

Sims Portex , Ltd.

FDA 510(k) clearance K012277 for PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE, Substantially Equivalent on 2002-02-11. Applicant: Sims Portex , Ltd..

Clearance details

Applicant: Sims Portex , Ltd.
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 2001-07-19
Decision date: 2002-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hythe, Kent, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code HHW

product code HHW

Malfunction: 485
Total: 485

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.