Cleared Traditional

K042809 - CUFFPATCH

K042809 is an FDA 510(k) clearance for CUFFPATCH, manufactured by Organogenesis, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K042809 · Organogenesis, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
21d
Days
Class 2
Risk

K042809 is an FDA 510(k) clearance for the CUFFPATCH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Organogenesis, Inc. (Canton, US). The FDA issued a Cleared decision on November 2, 2004 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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.

View all Organogenesis, Inc. devices

FDA 510(k) Submission Details - K042809

510(k) Number K042809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date November 02, 2004
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - FTM Mesh, Surgical

All 67
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K042809.
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SIS PLASTIC SURGERY MATRIX
K034039 · Cook Biotech, Inc. · Feb 2004