Cleared Traditional

K030269 - GENICON CLIP APPLIER

K030269 is an FDA 510(k) clearance for GENICON CLIP APPLIER, manufactured by Genicon, LC. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K030269 · Genicon, LC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
52d
Days
Class 2
Risk

K030269 is an FDA 510(k) clearance for the GENICON CLIP APPLIER. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Genicon, LC (Orlando, US). The FDA issued a Cleared decision on March 20, 2003 after a review of 52 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. 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.

FDA 510(k) Submission Details - K030269

510(k) Number K030269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2003
Decision Date March 20, 2003
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
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 176
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K030269.
14G CORMARK BIOPSY SITE IDENTIFIER
K032217 · Artemis Medical, Inc. · Aug 2003
FAST THROW STAINLESS STEEL SURGICAL SUTURE
K030926 · Advanced Surgical Products, Inc. · Jul 2003
MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
K031623 · Coalescent Surgical · Jul 2003
HEM-O-LOK XL CLIP
K030311 · Weck · Feb 2003
COALESCENT SURGICAL U-CLIP AND ACCESSORIES
K024366 · Coalescent Surgical · Jan 2003
SANARUS INDICA MARKER SYSTEM
K020054 · Sanarus Medical, Inc. · Oct 2002
K030269 · GENICON CLIP APPLIER
Download PDF FDA Summary Genicon, LC