ADVANCE SUTURE NONABSORBABLE NYLON SUTURE— 510(k) K903177

Name: FDA 510(k) clearance K903177
Creator: U.S. Food and Drug Administration
Published: 1991-06-28

Substantially Equivalent

Advance Suture, Inc.

FDA 510(k) clearance K903177 for ADVANCE SUTURE NONABSORBABLE NYLON SUTURE, Substantially Equivalent on 1991-06-28. Applicant: Advance Suture, Inc.. Device class: 2.

Clearance details

Applicant: Advance Suture, Inc.
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
Advisory panel: General, Plastic Surgery
Date received: 1990-07-18
Decision date: 1991-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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K903175 — ADVANCE SUTURE NONABSORBABLE DACRON SUTURE1991-07-26
K903174 — ADVANCE SUTURE ABSORBABLE GUT SUTURE1991-07-10
K903176 — ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTURE1991-06-28
K905454 — ADVANCE SUTURE NONABSORBABLE SILK SUTURE1991-06-28

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.