Cleared Special

K052482 - ARTELON SURGICAL SUTURE

K052482 is an FDA 510(k) clearance for ARTELON SURGICAL SUTURE, manufactured by Artimplant AB. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Special 510(k) pathway after a 38-day FDA review.

K052482 · Artimplant AB · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
38d
Days
Class 2
Risk

K052482 is an FDA 510(k) clearance for the ARTELON SURGICAL SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Artimplant AB (Washington, US). The FDA issued a Cleared decision on October 17, 2005 after a review of 38 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5020 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K052482

510(k) Number K052482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2005
Decision Date October 17, 2005
Days to Decision 38 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

GAR Device Classification - Class 2, Special Controls

Product Code GAR Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5020
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 56
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K052482.
MANI NEEDLE & SUTURE PACK (NYLON)
K053637 · Mani, Inc. · May 2006
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528 · Aesculap, Inc. · Mar 2006
QUILL NONABSORBABLE NYLON BARBED SUTURE
K052900 · Quill Medical, Inc. · Nov 2005
TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
K041510 · Sutures India Private Limited · Jun 2005
UNIMIDE
K042284 · United Medical Industries Co. , Ltd. · Dec 2004
NYLON THREADED NEEDLE
K042367 · Aros Surgical Instruments Corp. · Oct 2004
K052482 · ARTELON SURGICAL SUTURE
Download PDF FDA Summary Artimplant AB