ARTELON SURGICAL SUTURE— 510(k) K052482

Name: FDA 510(k) clearance K052482
Creator: U.S. Food and Drug Administration
Published: 2005-10-17

Substantially Equivalent

Artimplant AB

FDA 510(k) clearance K052482 for ARTELON SURGICAL SUTURE, Substantially Equivalent on 2005-10-17. Applicant: Artimplant AB. Device class: 2.

Clearance details

Applicant: Artimplant AB
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
Advisory panel: General, Plastic Surgery
Date received: 2005-09-09
Decision date: 2005-10-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K212603 — Non Absorbable Surgical Nylon Suture2021-12-22
K192420 — Crownjun Nylon Suture2020-05-29

More clearances from Artimplant AB

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K071887 — SPORTMESH OR ARTELON TISSUE REINFORCEMENT2007-09-18
K061956 — ARTELON STT SPACER2007-06-07
K061954 — ARTELON CMC SPACER ARTHRO2007-06-01
K052830 — SPORTMESH2006-01-19
K040070 — ARTELON SPACER CMC-12004-09-21

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.