Cleared Traditional

K040821 - COALESCENT SURGICAL U-CLIP AND ACCESSORIES

K040821 is an FDA 510(k) clearance for COALESCENT SURGICAL U-CLIP AND ACCESSORIES, manufactured by Coalescent Surgical. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K040821 · Coalescent Surgical · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
24d
Days
Class 2
Risk

K040821 is an FDA 510(k) clearance for the 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 April 23, 2004 after a review of 24 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 - K040821

510(k) Number K040821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2004
Decision Date April 23, 2004
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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 K040821.
COMPRESSION ANASTOMOSIS CLIP (CAC)
K041751 · Niti Medical Technologies , Ltd. · Sep 2004
COMPRESSION ANASTOMOSIS CLIP (CAC)
K033324 · Niti Medical Technologies , Ltd. · May 2004
SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
K040602 · Design Standards Corp. · May 2004
CORLINK AUTOMATED ANASTOMOTIC SYSTEM
K033979 · By-Pass Makafim , Ltd. · Mar 2004
ANSON REFIX VASCULAR AND TISSUE CLIP, MODELS GF-04-01 AND GF-04-02
K032896 · Anson Medical , Ltd. · Mar 2004
AMI REPROCESSED MULTIPLE CLIP APPLIERS
K032980 · Vanguard Medical Concepts, Inc. · Dec 2003
K040821 · COALESCENT SURGICAL U-CLIP AND ACCESSORIES
Download PDF FDA Summary Coalescent Surgical