FUJINON FORCEPS -- MODIFICATION— 510(k) K922396

Name: FDA 510(k) clearance K922396
Creator: U.S. Food and Drug Administration
Published: 1992-12-10

Substantially Equivalent

Hobbs Medical, Inc.

FDA 510(k) clearance K922396 for FUJINON FORCEPS -- MODIFICATION, Substantially Equivalent on 1992-12-10. Applicant: Hobbs Medical, Inc.. Device class: 1.

Clearance details

Applicant: Hobbs Medical, Inc.
Product code: Code FCL
Device class: Class 1
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1992-05-19
Decision date: 1992-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stafford Springs, CT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FCL

product code FCL

Death: 5
Total: 5

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.