SUMP DRAIN, W/FILTER, ARGYLE EDLICH— 510(k) K770442

Name: FDA 510(k) clearance K770442
Creator: U.S. Food and Drug Administration
Published: 1977-03-30

Substantially Equivalent

Sherwood Medical Industries

FDA 510(k) clearance K770442 for SUMP DRAIN, W/FILTER, ARGYLE EDLICH, Substantially Equivalent on 1977-03-30. Applicant: Sherwood Medical Industries. Device class: 1.

Clearance details

Applicant: Sherwood Medical Industries
Product code: Code GBX
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1977-03-07
Decision date: 1977-03-30
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 GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.