CANNULA, PERFUSION, FALLOPIAN TUBE— 510(k) K772230

Name: FDA 510(k) clearance K772230
Creator: U.S. Food and Drug Administration
Published: 1978-01-03

Substantially Equivalent

J. Sklar Mfg. Co., Inc.

FDA 510(k) clearance K772230 for CANNULA, PERFUSION, FALLOPIAN TUBE, Substantially Equivalent on 1978-01-03. Applicant: J. Sklar Mfg. Co., Inc.. Device class: 2.

Clearance details

Applicant: J. Sklar Mfg. Co., Inc.
Product code: Code LKF
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1977-12-06
Decision date: 1978-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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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.