Cleared Special

K031623 - MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES

K031623 is an FDA 510(k) clearance for MODIFICATION TO COALESCENT SURGICAL U-C..., manufactured by Coalescent Surgical. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Special 510(k) pathway after a 41-day FDA review.

K031623 · Coalescent Surgical · 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
41d
Days
Class 2
Risk

K031623 is an FDA 510(k) clearance for the MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Coalescent Surgical (Sunnyvale, US). The FDA issued a Cleared decision on July 3, 2003 after a review of 41 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.

FDA 510(k) Submission Details - K031623

510(k) Number K031623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2003
Decision Date July 03, 2003
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
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 176
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K031623.
TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER
K032238 · Neurosel (Medical) Limited · Sep 2003
14G CORMARK BIOPSY SITE IDENTIFIER
K032217 · Artemis Medical, Inc. · Aug 2003
FAST THROW STAINLESS STEEL SURGICAL SUTURE
K030926 · Advanced Surgical Products, Inc. · Jul 2003
GENICON CLIP APPLIER
K030269 · Genicon, LC · Mar 2003
HEM-O-LOK XL CLIP
K030311 · Weck · Feb 2003
COALESCENT SURGICAL U-CLIP AND ACCESSORIES
K024366 · Coalescent Surgical · Jan 2003
K031623 · MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
Download PDF FDA Summary Coalescent Surgical