VILLALTA RETRACTOR— 510(k) K943875

Name: FDA 510(k) clearance K943875
Creator: U.S. Food and Drug Administration
Published: 1994-11-09

Substantially Equivalent

Hct, Inc.

FDA 510(k) clearance K943875 for VILLALTA RETRACTOR, Substantially Equivalent on 1994-11-09. Applicant: Hct, Inc.. Device class: 1.

Clearance details

Applicant: Hct, Inc.
Product code: Code GAD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1994-08-08
Decision date: 1994-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.