ATRIUM PROLITE S MESH— 510(k) K082748

Name: FDA 510(k) clearance K082748
Creator: U.S. Food and Drug Administration
Published: 2009-01-14

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K082748 for ATRIUM PROLITE S MESH, Substantially Equivalent on 2009-01-14. Applicant: Atrium Medical Corp.. Device class: 2.

Clearance details

Applicant: Atrium Medical Corp.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2008-09-19
Decision date: 2009-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Hudson, NH, US

Download summary PDF View on FDA.gov ↗

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K121070 — C-QUR RPM MESH2012-04-26
K113112 — CLEARWAY RX NB CATHETER2011-11-17
K102596 — ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT2010-10-05

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.