Cleared Traditional

K030926 - FAST THROW STAINLESS STEEL SURGICAL SUTURE

K030926 is an FDA 510(k) clearance for FAST THROW STAINLESS STEEL SURGICAL SUTURE, manufactured by Advanced Surgical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K030926 · Advanced Surgical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
119d
Days
Class 2
Risk

K030926 is an FDA 510(k) clearance for the FAST THROW STAINLESS STEEL SURGICAL SUTURE. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Advanced Surgical Products, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 21, 2003 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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 - K030926

510(k) Number K030926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2003
Decision Date July 21, 2003
Days to Decision 119 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
4d slower than avg
Panel avg: 115d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZP Device Classification - Class 2, Special Controls

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - FZP Clip, Implantable

All 177
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K030926.
MODIFICATION TO SUTURE CLINCH
K033024 · Applied Medical Resources Corp. · Oct 2003
TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER
K032238 · Neurosel (Medical) Limited · Sep 2003
14G CORMARK BIOPSY SITE IDENTIFIER
K032217 · Artemis Medical, Inc. · Aug 2003
MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
K031623 · Coalescent Surgical · Jul 2003
GENICON CLIP APPLIER
K030269 · Genicon, LC · Mar 2003
HEM-O-LOK XL CLIP
K030311 · Weck · Feb 2003
K030926 · FAST THROW STAINLESS STEEL SURGICAL SUTURE
Download PDF FDA Summary Advanced Surgical Pro…