VENESECTION TRAY, ADULT 6050— 510(k) K843627

Name: FDA 510(k) clearance K843627
Creator: U.S. Food and Drug Administration
Published: 1984-12-04

Substantially Equivalent

Pro-Lab, Inc.

FDA 510(k) clearance K843627 for VENESECTION TRAY, ADULT 6050, Substantially Equivalent on 1984-12-04. Applicant: Pro-Lab, Inc.. Device class: 1.

Clearance details

Applicant: Pro-Lab, Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1984-09-14
Decision date: 1984-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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.