KOGAN ENDOSPECULUM 9-1/2— 510(k) K842111

Name: FDA 510(k) clearance K842111
Creator: U.S. Food and Drug Administration
Published: 1984-06-19

Substantially Equivalent

J. Sklar Mfg. Co., Inc.

FDA 510(k) clearance K842111 for KOGAN ENDOSPECULUM 9-1/2, Substantially Equivalent on 1984-06-19. Applicant: J. Sklar Mfg. Co., Inc.. Device class: 1.

Clearance details

Applicant: J. Sklar Mfg. Co., Inc.
Product code: Code HTZ
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1984-05-29
Decision date: 1984-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTZ

product code HTZ

Malfunction: 1,133
Total: 1,133

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.