Cleared Traditional

K961811 - PERI-GUARD PERICARDIUM

K961811 is an FDA 510(k) clearance for PERI-GUARD PERICARDIUM, manufactured by Bio-Vascular, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K961811 · Bio-Vascular, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
34d
Days
Class 2
Risk

K961811 is an FDA 510(k) clearance for the PERI-GUARD PERICARDIUM. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Bio-Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 13, 1996 after a review of 34 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 Bio-Vascular, Inc. devices

FDA 510(k) Submission Details - K961811

510(k) Number K961811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1996
Decision Date June 13, 1996
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
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 66
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K961811.
SURGISIS
K980431 · Cook Biotech, Inc. · May 1998
PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
K971048 · Bio-Vascular, Inc. · May 1997
SUPPLE PERI-GUARD PERICARDIUM
K961810 · Bio-Vascular, Inc. · Jun 1996
PERI-STRIPS
K940205 · Bio-Vascular, Inc. · May 1994
SUPPLE PERI-GUARD
K923657 · Bio-Vascular, Inc. · Dec 1992
PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH
K915774 · Ethicon, Inc. · Mar 1992