STRAITH DRAIN INSERTER— 510(k) K840835

Name: FDA 510(k) clearance K840835
Creator: U.S. Food and Drug Administration
Published: 1984-04-23

Substantially Equivalent

Surgical Technology Laboratories, Inc.

FDA 510(k) clearance K840835 for STRAITH DRAIN INSERTER, Substantially Equivalent on 1984-04-23. Applicant: Surgical Technology Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Surgical Technology Laboratories, Inc.
Product code: Code FZX
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1984-02-24
Decision date: 1984-04-23
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 FZX

product code FZX

Injury: 797
Malfunction: 3,815
Total: 4,612

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.