Cleared Traditional

K133890 - AESCULAP OPTILENE NONABSORBABLE SUTURE

K133890 is an FDA 510(k) clearance for AESCULAP OPTILENE NONABSORBABLE SUTURE, manufactured by Aesculap, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K133890 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
207d
Days
Class 2
Risk

K133890 is an FDA 510(k) clearance for the AESCULAP OPTILENE NONABSORBABLE SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on July 15, 2014 after a review of 207 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - 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 - K133890

510(k) Number K133890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2013
Decision Date July 15, 2014
Days to Decision 207 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
92d slower than avg
Panel avg: 115d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAW Device Classification - Class 2, Special Controls

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 80
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K133890.
Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design
K151112 · Angiotech · Sep 2015
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
K141206 · Edwards Lifesciences, LLC · Jan 2015
StitchKit
K142639 · Origami Surgical, LLC · Dec 2014
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
K133356 · Ethicon, Inc. · Dec 2013
SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE
K131224 · Surgical Specialties Corp. Dba Angiotech · May 2013
QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K130078 · Surgical Specialties Corp. Dba Angiotech · Feb 2013
K133890 · AESCULAP OPTILENE NONABSORBABLE SUTURE
Download PDF FDA Summary Aesculap, Inc.