SERISCAFFOLD SURGICAL MESH— 510(k) K080442

Name: FDA 510(k) clearance K080442
Creator: U.S. Food and Drug Administration
Published: 2008-11-13

Substantially Equivalent

Serica Technologies, Inc.

FDA 510(k) clearance K080442 for SERISCAFFOLD SURGICAL MESH, Substantially Equivalent on 2008-11-13. Applicant: Serica Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Serica Technologies, Inc.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2008-02-19
Decision date: 2008-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medford, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTL

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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
K250869 — Parietene Macroporous Mesh (PPM5050 )2025-04-23

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 →

Recalls naming K080442

K-number listed on FDA's recall record

Z-0794-2013 — SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.Class II·Terminated·Allergen Medical·20130108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080442.

Data sourced from openFDA. This site is unofficial and independent of the FDA.