DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE— 510(k) K093112

Name: FDA 510(k) clearance K093112
Creator: U.S. Food and Drug Administration
Published: 2010-02-01

Substantially Equivalent

Coloplast Manufacturing Us, LLC

FDA 510(k) clearance K093112 for DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE, Substantially Equivalent on 2010-02-01. Applicant: Coloplast Manufacturing Us, LLC. Device class: 2.

Clearance details

Applicant: Coloplast Manufacturing Us, LLC
Product code: Code GAW
Device class: Class 2
Regulation: 21 CFR 878.5010
Advisory panel: General, Plastic Surgery
Date received: 2009-10-01
Decision date: 2010-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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

More clearances from Coloplast Manufacturing Us, LLC

view all

K100878 — SELF CATH CATHETER2010-05-26
K082640 — VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM2008-10-17
K070939 — SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM2007-06-01

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.