Cleared Traditional

K011372 - AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE

K011372 is an FDA 510(k) clearance for AESCULAP, 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 89-day FDA review.

K011372 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
89d
Days
Class 2
Risk

K011372 is an FDA 510(k) clearance for the AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Aesculap, Inc. (San Diego, US). The FDA issued a Cleared decision on August 1, 2001 after a review of 89 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. 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.

View all Aesculap, Inc. devices

FDA 510(k) Submission Details - K011372

510(k) Number K011372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2001
Decision Date August 01, 2001
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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 122
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K011372.
COATED VICRYL* (POLYGLACTIN 910) SUTURE
K022269 · Ethicon, Inc. · Sep 2002
SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED
K014021 · Surgical Specialties Corp · Jan 2002
L-25 ABSORBABLE SURIGCAL SUTURE
K013671 · United States Surgical, A Division of Tyco Healthc · Jan 2002
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011375 · Aesculap, Inc. · Jun 2001
BIOKNOTLESS ANCHOR
K002639 · Mitek Products · May 2001
POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)
K002190 · Cp Medical · Aug 2000