Cleared Traditional

K062320 - SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100

K062320 is an FDA 510(k) clearance for SURGISIS PEYRONIE'S REPAIR GRAFT, manufactured by Cook Biotech, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K062320 · Cook Biotech, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
54d
Days
Class 2
Risk

K062320 is an FDA 510(k) clearance for the SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on October 2, 2006 after a review of 54 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 Cook Biotech, Inc. devices

FDA 510(k) Submission Details - K062320

510(k) Number K062320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2006
Decision Date October 02, 2006
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
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 133
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K062320.
BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106
K063178 · C.R. Bard, Inc. · Nov 2006
SURGISIS, SURGISIS ES
K062696 · Cook Biotech, Inc. · Oct 2006
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
K062729 · Cook Biotech, Inc. · Oct 2006
ZIMMER COLLAGEN REPAIR PATCH
K053562 · Tissue Science Laboratories, Plc · Jun 2006
COSMATRIX
K060829 · Tei Biosciences, Inc. · May 2006
XENFORM SOFT TISSUE REPAIR MATRIX
K060984 · Tei Biosciences, Inc. · May 2006