Reperen Surgical Mesh— 510(k) K170134

Name: FDA 510(k) clearance K170134
Creator: U.S. Food and Drug Administration
Published: 2017-08-09

Substantially Equivalent

Iconlab, Inc.

FDA 510(k) clearance K170134 for Reperen Surgical Mesh, Substantially Equivalent on 2017-08-09. Applicant: Iconlab, Inc.. Device class: 2.

Clearance details

Applicant: Iconlab, Inc.
Product code: Product code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2017-01-17
Decision date: 2017-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTL

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K260474 — Liora Monofilament Scaffold2026-09-28
K253956 — ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)2026-05-21
K253125 — Parietene Flat Sheet Mesh2025-10-24
K251955 — Onflex Mesh2025-07-24
K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped2025-06-12

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.