COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205— 510(k) K003323

Name: FDA 510(k) clearance K003323
Creator: U.S. Food and Drug Administration
Published: 2001-01-22

Substantially Equivalent

Davol, Inc.

FDA 510(k) clearance K003323 for COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205, Substantially Equivalent on 2001-01-22. Applicant: Davol, Inc.. Device class: 2.

Clearance details

Applicant: Davol, Inc.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2000-10-24
Decision date: 2001-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranston, RI, US

Download summary PDF View on FDA.gov ↗

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K003790 — DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 55520052000-12-22
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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.