BIOMARC TISSUE MARKER— 510(k) K032347

Name: FDA 510(k) clearance K032347
Creator: U.S. Food and Drug Administration
Published: 2003-08-21

Substantially Equivalent

Carbon Medical Technologies, Inc.

FDA 510(k) clearance K032347 for BIOMARC TISSUE MARKER, Substantially Equivalent on 2003-08-21. Applicant: Carbon Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Carbon Medical Technologies, Inc.
Product code: Product code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2003-07-30
Decision date: 2003-08-21
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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K172227 — Endoscopic Injection Needle2017-08-23
K133148 — BIOMARC COAXIAL NEEDLE2014-05-13

Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.