SUTURE FIXATION DEVICE; MESH FIXATION DEVICE— 510(k) K021834

Name: FDA 510(k) clearance K021834
Creator: U.S. Food and Drug Administration
Published: 2002-08-28

Substantially Equivalent

Mle, Inc.

FDA 510(k) clearance K021834 for SUTURE FIXATION DEVICE; MESH FIXATION DEVICE, Substantially Equivalent on 2002-08-28. Applicant: Mle, Inc.. Device class: 2.

Clearance details

Applicant: Mle, Inc.
Product code: Code GAW
Device class: Class 2
Regulation: 21 CFR 878.5010
Advisory panel: General, Plastic Surgery
Date received: 2002-06-04
Decision date: 2002-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Grafton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAW

view all

K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device2026-03-27
K233355 — Cypris eXact Suturing System2024-01-12
K230746 — Non absorbable Surgical Polypropylene Suture2023-09-14
K221280 — Vesseal2022-12-09
K211178 — DURAMESH Mesh Suture2022-09-02

Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.