Cleared Traditional

K030926 - FAST THROW STAINLESS STEEL SURGICAL SUTURE

K030926 is the FDA 510(k) clearance for FAST THROW STAINLESS STEEL SURGICAL SUTURE by Advanced Surgical Products, Inc.. It is a Class 2 General & Plastic Surgery device (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
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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.

View all Advanced Surgical Products, Inc. devices

Submission Details

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.

Device Classification

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 100
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K030926.
LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER
K050344 · Ethicon Endo-Surgery, Inc. · Mar 2005
AMI REPROCESSED MULTIPLE CLIP APPLIERS
K032980 · Vanguard Medical Concepts, Inc. · Dec 2003
MODIFICATION TO SUTURE CLINCH
K033024 · Applied Medical Resources Corp. · Oct 2003
AMS SOFT-TISSUE APPROXIMATION SYSTEM
K012342 · American Medical Systems, Inc. · Sep 2001
MODIFICATION TO IMPLANTABLE CLIP
K011236 · Applied Medical Resources Corp. · May 2001
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450 · United States Surgical, A Division of Tyco Healthc · Jul 2000