Cleared Traditional

K973379 - STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS

K973379 is an FDA 510(k) clearance for STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS, manufactured by S. Jackson, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K973379 · S. Jackson, Inc. · General & Plastic Surgery device
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Sep 1997
Decision
17d
Days
Class 2
Risk

K973379 is an FDA 510(k) clearance for the STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by S. Jackson, Inc. (Alexandria, US). The FDA issued a Cleared decision on September 25, 1997 after a review of 17 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 S. Jackson, Inc. devices

FDA 510(k) Submission Details - K973379

510(k) Number K973379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date September 25, 1997
Days to Decision 17 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 115d · This submission: 17d
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 134
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K973379.
PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
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SURGISIS
K980431 · Cook Biotech, Inc. · May 1998
PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
K971048 · Bio-Vascular, Inc. · May 1997
GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING
K963175 · Glycar, Inc. · Sep 1996
SUPPLE PERI-GUARD PERICARDIUM
K961810 · Bio-Vascular, Inc. · Jun 1996