Cleared Special

K983162 - PERI-GUARD

K983162 is an FDA 510(k) clearance for PERI-GUARD, manufactured by Bio-Vascular, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Special 510(k) pathway after a 29-day FDA review.

K983162 · Bio-Vascular, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
29d
Days
Class 2
Risk

K983162 is an FDA 510(k) clearance for the PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE.... 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 October 9, 1998 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bio-Vascular, Inc. devices

FDA 510(k) Submission Details - K983162

510(k) Number K983162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1998
Decision Date October 09, 1998
Days to Decision 29 days
Submission Type Special
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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K983162.
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K030782 · W.L. Gore & Associates, Inc. · Apr 2003
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K001738 · DePuy Orthopaedics, Inc. · Dec 2000
PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
K992537 · Bio-Vascular, Inc. · Feb 2000
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K982330 · Depuy, Inc. · Sep 1998
SURGISIS
K980431 · Cook Biotech, Inc. · May 1998
PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
K971048 · Bio-Vascular, Inc. · May 1997