QUILL NONABSORBABLE NYLON BARBED SUTURE— 510(k) K052900

Name: FDA 510(k) clearance K052900
Creator: U.S. Food and Drug Administration
Published: 2005-11-28

Substantially Equivalent

Quill Medical, Inc.

FDA 510(k) clearance K052900 for QUILL NONABSORBABLE NYLON BARBED SUTURE, Substantially Equivalent on 2005-11-28. Applicant: Quill Medical, Inc.. Device class: 2.

Clearance details

Applicant: Quill Medical, Inc.
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
Advisory panel: General, Plastic Surgery
Date received: 2005-10-14
Decision date: 2005-11-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Research Triangle Park, NC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Quill Medical, Inc.

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K052373 — QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE2005-09-26
K051609 — QUILL SYNTHETIC ABSORBABLE BARBED SUTURE2005-08-04
K042075 — QUILL SYNTHETIC ABSORBABLE BARBED SUTURE2004-10-26

Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.