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

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..

Clearance details

Applicant
J. Sklar Mfg. Co., Inc.
Product code
Code LKF
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LKF

product code LKF
Malfunction
643
Other
2
Total
645

Source: openFDA MAUDE database, through . 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.