Cleared Special

K033024 - MODIFICATION TO SUTURE CLINCH

K033024 is an FDA 510(k) clearance for MODIFICATION TO SUTURE CLINCH, manufactured by Applied Medical Resources Corp.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Special 510(k) pathway after a 28-day FDA review.

K033024 · Applied Medical Resources Corp. · General & Plastic Surgery device
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Oct 2003
Decision
28d
Days
Class 2
Risk

K033024 is an FDA 510(k) clearance for the MODIFICATION TO SUTURE CLINCH. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on October 24, 2003 after a review of 28 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Applied Medical Resources Corp. devices

FDA 510(k) Submission Details - K033024

510(k) Number K033024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2003
Decision Date October 24, 2003
Days to Decision 28 days
Submission Type Special
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
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 104
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K033024.
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
K051125 · Abbott Laboratories · Jun 2005
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
FAST THROW STAINLESS STEEL SURGICAL SUTURE
K030926 · Advanced Surgical Products, Inc. · Jul 2003
AMS SOFT-TISSUE APPROXIMATION SYSTEM
K012342 · American Medical Systems, Inc. · Sep 2001
BIOPSY SITE MARKER
K011402 · Senorx, Inc. · Jul 2001