OVAMED FALLOPIAN OSTIAL ACCESS CATHETER— 510(k) K931167

Substantially Equivalent

Ovamed Corp.

FDA 510(k) clearance K931167 for OVAMED FALLOPIAN OSTIAL ACCESS CATHETER, Substantially Equivalent on 1995-06-22. Applicant: Ovamed Corp..

Clearance details

Applicant: Ovamed Corp.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 1993-03-08
Decision date: 1995-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, 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.