Cleared Traditional

K972412 - PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH

K972412 is an FDA 510(k) clearance for PROLENE POLYPROPYLENE MESH HERNIA DEVIC..., manufactured by Ethicon, 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.

K972412 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
76d
Days
Class 2
Risk

K972412 is an FDA 510(k) clearance for the PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on September 10, 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 Ethicon, Inc. devices

FDA 510(k) Submission Details - K972412

510(k) Number K972412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1997
Decision Date September 10, 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 267
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K972412.
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
K981051 · W.L. Gore & Associates, Inc. · Apr 1998
SOFTFORM FACIAL IMPLANT
K973462 · Tissue Technologies, Inc. · Nov 1997
VENTRAL WALL DEFECT REDUCTION SILO
K973082 · Specialty Surgical Products, Inc. · Nov 1997
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