Cleared Special

K031286 - SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE

K031286 is an FDA 510(k) clearance for SAFIL AND SAFIL QUICK SYNTHETIC ABSORBA..., manufactured by Aesculap, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Special 510(k) pathway after a 36-day FDA review.

K031286 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
36d
Days
Class 2
Risk

K031286 is an FDA 510(k) clearance for the SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on May 29, 2003 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - 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 - K031286

510(k) Number K031286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2003
Decision Date May 29, 2003
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

GAM Device Classification - Class 2, Special Controls

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 149
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K031286.
ORTHODEK
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K032420 · Ethicon, Inc. · Oct 2003
VISORB SWIFT
K023710 · Cp Medical · Jan 2003
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE
K022715 · Ethicon, Inc. · Dec 2002
ASSUFIL
K021767 · Assut Europe S.P.A. · Nov 2002
K031286 · SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
Download PDF FDA Summary Aesculap, Inc.