FSSB NYLON SURGICAL SUTURES— 510(k) K060471

Name: FDA 510(k) clearance K060471
Creator: U.S. Food and Drug Administration
Published: 2006-07-26

Substantially Equivalent

Fssb Chirurgische Nadeln GmbH

FDA 510(k) clearance K060471 for FSSB NYLON SURGICAL SUTURES, Substantially Equivalent on 2006-07-26. Applicant: Fssb Chirurgische Nadeln GmbH. Device class: 2.

Clearance details

Applicant: Fssb Chirurgische Nadeln GmbH
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
Advisory panel: General, Plastic Surgery
Date received: 2006-02-23
Decision date: 2006-07-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAR

view all

K261484 — Tissue Approximation System2026-06-03
K220980 — Tissue Approximation System (TAS)2023-07-05
K212888 — Golnit Nylon Monofilament Suture2022-03-31
K212603 — Non Absorbable Surgical Nylon Suture2021-12-22
K192420 — Crownjun Nylon Suture2020-05-29

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.