SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME— 510(k) K100593

Name: FDA 510(k) clearance K100593
Creator: U.S. Food and Drug Administration
Published: 2010-10-13

Substantially Equivalent

Lsi Solutions, Inc.

FDA 510(k) clearance K100593 for SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME, Substantially Equivalent on 2010-10-13. Applicant: Lsi Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Lsi Solutions, Inc.
Product code: Code GAW
Device class: Class 2
Regulation: 21 CFR 878.5010
Advisory panel: General, Plastic Surgery
Date received: 2010-03-02
Decision date: 2010-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Victor, NY, 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.

Clearance details

Recent devices under product code GAW

More clearances from Lsi Solutions, Inc.

Adverse events under product code GAW