BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX— 510(k) K021835

Name: FDA 510(k) clearance K021835
Creator: U.S. Food and Drug Administration
Published: 2002-10-17

Substantially Equivalent

Brennen Medical, Inc.

FDA 510(k) clearance K021835 for BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX, Substantially Equivalent on 2002-10-17. Applicant: Brennen Medical, Inc.. Device class: 2.

Clearance details

Applicant: Brennen Medical, Inc.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2002-06-04
Decision date: 2002-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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K050086 — BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING2006-02-17
K030460 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX2003-03-07
K002077 — GLUCANPRO CREAM2000-10-02
K002078 — BETA GLUCAN GEL (MACROPRO GEL)2000-10-02
K000518 — MACROPRO GEL2000-05-01

Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.