HSG CATHETER SET— 510(k) K041094

Substantially Equivalent

Bioteque America, Inc.

FDA 510(k) clearance K041094 for HSG CATHETER SET, Substantially Equivalent on 2004-06-17. Applicant: Bioteque America, Inc..

Clearance details

Applicant: Bioteque America, Inc.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2004-04-27
Decision date: 2004-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, US

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Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

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.