PESSARY FLEXIBLE SILICONE DONUT RING— 510(k) K920747

Substantially Equivalent

Bioteque America, Inc.

FDA 510(k) clearance K920747 for PESSARY FLEXIBLE SILICONE DONUT RING, Substantially Equivalent on 1994-08-29. Applicant: Bioteque America, Inc..

Clearance details

Applicant: Bioteque America, Inc.
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 1992-02-19
Decision date: 1994-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, US

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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.