Cleared Traditional

K964857 - RAPISEAL PATCH

K964857 is an FDA 510(k) clearance for RAPISEAL PATCH, manufactured by Fusion Medical Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K964857 · Fusion Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
76d
Days
Class 2
Risk

K964857 is an FDA 510(k) clearance for the RAPISEAL PATCH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Fusion Medical Technologies, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 18, 1997 after a review of 76 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 Fusion Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K964857

510(k) Number K964857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1996
Decision Date February 18, 1997
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
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 - FTL Mesh, Surgical, Polymeric

All 223
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K964857.
BARD COMPOSITE PROSTHESIS
K971745 · Davol Inc., Sub. C. R. Bard, Inc. · Aug 1997
GRAFT PATCH
K970561 · Organogenesis, Inc. · Aug 1997
SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA
K971472 · Technical Products, Inc. · Jul 1997
GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE
K965038 · W.L. Gore & Associates, Inc. · Feb 1997
S.A.M. FACIAL IMPLANT W/INTRODUCER
K964761 · W.L. Gore & Associates, Inc. · Jan 1997
SURGICAL FABRICS
K963226 · Boston Scientific Corp · Nov 1996