Cleared Traditional

K012201 - PREMICRON NONABSORBABLE PET SURGICAL SUTURE

K012201 is an FDA 510(k) clearance for PREMICRON NONABSORBABLE PET SURGICAL SUTURE, manufactured by Aesculap, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K012201 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
68d
Days
Class 2
Risk

K012201 is an FDA 510(k) clearance for the PREMICRON NONABSORBABLE PET SURGICAL SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Aesculap, Inc. (San Diego, US). The FDA issued a Cleared decision on September 19, 2001 after a review of 68 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K012201

510(k) Number K012201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2001
Decision Date September 19, 2001
Days to Decision 68 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
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAT Device Classification - Class 2, Special Controls

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 175
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K012201.
SERRALESTER
K020902 · Serral, S.A. DE C.V. · May 2002
LIFESTITCH SUTURING DEVICE
K013990 · Edwards Lifesciences, LLC · Feb 2002
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
K012923 · Arthrex, Inc. · Oct 2001
POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)
K002172 · Xiros Plc · Aug 2001
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
K010673 · Arthrex, Inc. · May 2001
GRAMS POLYESTER NONABSORBABLE SUTURE
K003590 · Gramsmed, LLC · Mar 2001
K012201 · PREMICRON NONABSORBABLE PET SURGICAL SUTURE
Download PDF FDA Summary Aesculap, Inc.