Cleared Traditional

K971048 - PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT

K971048 is an FDA 510(k) clearance for PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT, 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 49-day FDA review.

K971048 · Bio-Vascular, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
49d
Days
Class 2
Risk

K971048 is an FDA 510(k) clearance for the PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT. 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 May 9, 1997 after a review of 49 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 - K971048

510(k) Number K971048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1997
Decision Date May 09, 1997
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
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 K971048.
PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
K983162 · Bio-Vascular, Inc. · Oct 1998
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K982330 · Depuy, Inc. · Sep 1998
SURGISIS
K980431 · Cook Biotech, Inc. · May 1998
SUPPLE PERI-GUARD PERICARDIUM
K961810 · Bio-Vascular, Inc. · Jun 1996
PERI-GUARD PERICARDIUM
K961811 · Bio-Vascular, Inc. · Jun 1996
PERI-STRIPS
K940205 · Bio-Vascular, Inc. · May 1994