Cleared Traditional

K974540 - SIS HERNIA REPAIR DEVICE

K974540 is an FDA 510(k) clearance for SIS HERNIA REPAIR DEVICE, manufactured by Sentron Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K974540 · Sentron Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
168d
Days
Class 2
Risk

K974540 is an FDA 510(k) clearance for the SIS HERNIA REPAIR DEVICE. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Sentron Medical, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 20, 1998 after a review of 168 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sentron Medical, Inc. devices

FDA 510(k) Submission Details - K974540

510(k) Number K974540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1997
Decision Date May 20, 1998
Days to Decision 168 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
53d slower than avg
Panel avg: 115d · This submission: 168d
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 224
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K974540.
MESH, SURGICAL, POLYMERIC
K982575 · United States Surgical, A Division of Tyco Healthc · Nov 1998
SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL
K982475 · Tissue Technologies, Inc. · Sep 1998
SHELHIGH NO-REACT PNEUMOPLEDGETS
K981756 · Shelhigh, Inc. · Aug 1998
HERNIAMESH SURGICAL MESHES
K973955 · Herniamesh · May 1998
MENTOR SUSPEND SLING
K980483 · Mentor Corp. · Apr 1998
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
K981051 · W.L. Gore & Associates, Inc. · Apr 1998