FLAT CLOSED WOUND DRAIN WITH TROCAR— 510(k) K965146

Name: FDA 510(k) clearance K965146
Creator: U.S. Food and Drug Administration
Published: 1997-03-10

Substantially Equivalent

Axiom Medical, Inc.

FDA 510(k) clearance K965146 for FLAT CLOSED WOUND DRAIN WITH TROCAR, Substantially Equivalent on 1997-03-10. Applicant: Axiom Medical, Inc.. Device class: 1.

Clearance details

Applicant: Axiom Medical, Inc.
Product code: Code GBX
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1996-12-23
Decision date: 1997-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Dominguez, CA, 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.