HEMORRHOIDAL LIGATOR— 510(k) K790577

Substantially Equivalent

J. Sklar Mfg. Co., Inc.

FDA 510(k) clearance K790577 for HEMORRHOIDAL LIGATOR, Substantially Equivalent on 1979-04-23. Applicant: J. Sklar Mfg. Co., Inc..

Clearance details

Applicant
J. Sklar Mfg. Co., Inc.
Product code
Code HCF
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HCF

product code HCF
Death
6
Other
1
Total
7

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.