Cleared Abbreviated

K060471 - FSSB NYLON SURGICAL SUTURES

K060471 is an FDA 510(k) clearance for FSSB NYLON SURGICAL SUTURES, manufactured by Fssb Chirurgische Nadeln GmbH. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Abbreviated 510(k) pathway after a 153-day FDA review.

K060471 · Fssb Chirurgische Nadeln GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
153d
Days
Class 2
Risk

K060471 is an FDA 510(k) clearance for the FSSB NYLON SURGICAL SUTURES. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Fssb Chirurgische Nadeln GmbH (Washington, US). The FDA issued a Cleared decision on July 26, 2006 after a review of 153 days - an extended review 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K060471

510(k) Number K060471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2006
Decision Date July 26, 2006
Days to Decision 153 days
Submission Type Abbreviated
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
38d slower than avg
Panel avg: 115d · This submission: 153d
Pathway characteristics
Standards-based clearance path.

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 K060471.
RiverLon (Nylon) Suture
K152795 · Riverpoint Medical · Oct 2015
VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
K123034 · Unilene Sac · May 2013
KUMAR T-ANCHORS HERNIA SET
K081366 · Nashville Surgical Instruments · Jul 2008
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
K060471 · FSSB NYLON SURGICAL SUTURES
Download PDF FDA Summary Fssb Chirurgische Nad…