SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE— 510(k) K011105

Name: FDA 510(k) clearance K011105
Creator: U.S. Food and Drug Administration
Published: 2001-05-30

Substantially Equivalent

Qrc Consulting

FDA 510(k) clearance K011105 for SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE, Substantially Equivalent on 2001-05-30. Applicant: Qrc Consulting. Device class: 2.

Clearance details

Applicant: Qrc Consulting
Product code: Code GAL
Device class: Class 2
Regulation: 21 CFR 878.4830
Advisory panel: General, Plastic Surgery
Date received: 2001-04-11
Decision date: 2001-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkonton, MA, US

Download summary PDF View on FDA.gov ↗

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K030227 — SUTURTEK FASTCLOSE SUTURING DEVICE2003-03-17

Adverse events under product code GAL

product code GAL

Malfunction: 681
Other: 1
Total: 682

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.