Cleared Traditional

K122734 - AESCULAP NOVOSYN ABSORBABLE SUTURE

K122734 is an FDA 510(k) clearance for AESCULAP NOVOSYN ABSORBABLE SUTURE, manufactured by Aesculap, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K122734 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
103d
Days
Class 2
Risk

K122734 is an FDA 510(k) clearance for the AESCULAP NOVOSYN ABSORBABLE 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 December 18, 2012 after a review of 103 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K122734

510(k) Number K122734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2012
Decision Date December 18, 2012
Days to Decision 103 days
Submission Type Traditional
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
12d faster than avg
Panel avg: 115d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K122734.
SYNTHETIC ABSORBABLE SUTURE
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K130083 · Demetech Corp. · Jul 2013
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K123836 · Surgical Specialties Corp. Dba Angiotech · Dec 2012
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K123409 · Surgical Specialties Corp. Dba Angiotech · Nov 2012
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K122898 · Surgical Specialties Corp. Dba Angiotech · Oct 2012
VILET VILET QUICK
K120556 · Riverpoint Medical · May 2012
K122734 · AESCULAP NOVOSYN ABSORBABLE SUTURE
Download PDF FDA Summary Aesculap, Inc.