WALLACE ARTIFICIAL INSEMINATION CATHETER— 510(k) K061679

Substantially Equivalent

Irvine Scientific Sales Co., Inc.

FDA 510(k) clearance K061679 for WALLACE ARTIFICIAL INSEMINATION CATHETER, Substantially Equivalent on 2006-10-13. Applicant: Irvine Scientific Sales Co., Inc..

Clearance details

Applicant: Irvine Scientific Sales Co., Inc.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2006-06-15
Decision date: 2006-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, 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.