BIRCOLL BALLOON DISSECTOR— 510(k) K984448

Name: FDA 510(k) clearance K984448
Creator: U.S. Food and Drug Administration
Published: 1999-01-28

Substantially Equivalent

Wells Johnson Co.

FDA 510(k) clearance K984448 for BIRCOLL BALLOON DISSECTOR, Substantially Equivalent on 1999-01-28. Applicant: Wells Johnson Co.. Device class: 1.

Clearance details

Applicant: Wells Johnson Co.
Product code: Code FZW
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1998-12-14
Decision date: 1999-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FZW

product code FZW

Malfunction: 3,067
Total: 3,067

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.