BIOTEQUE VAGINAL DILATOR— 510(k) K003380

Substantially Equivalent

Bioteque America, Inc.

FDA 510(k) clearance K003380 for BIOTEQUE VAGINAL DILATOR, Substantially Equivalent on 2001-01-29. Applicant: Bioteque America, Inc..

Clearance details

Applicant: Bioteque America, Inc.
Product code: Code HDX
Advisory panel: Obstetrics/Gynecology
Date received: 2000-10-31
Decision date: 2001-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, US

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Adverse events under product code HDX

product code HDX

Other: 1
Total: 1

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.