HEISS RETRACTOR— 510(k) K771191

Name: FDA 510(k) clearance K771191
Creator: U.S. Food and Drug Administration
Published: 1977-07-11

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K771191 for HEISS RETRACTOR, Substantially Equivalent on 1977-07-11. Applicant: Edward Weck, Inc.. Device class: 1.

Clearance details

Applicant: Edward Weck, Inc.
Product code: Code GAD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1977-07-01
Decision date: 1977-07-11
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 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.