Cleared Traditional

K020705 - SIIS#1 TISSUE SUSPENSION SYSTEM

K020705 is an FDA 510(k) clearance for SIIS#1 TISSUE SUSPENSION SYSTEM, manufactured by Tag Medical Products. The device is a Class 2 Gastroenterology & Urology device with product code OTN cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K020705 · Tag Medical Products · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
53d
Days
Class 2
Risk

K020705 is an FDA 510(k) clearance for the SIIS#1 TISSUE SUSPENSION SYSTEM. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN), Class II - Special Controls.

Submitted by Tag Medical Products (Kibbutz Gaaton, IL). The FDA issued a Cleared decision on April 26, 2002 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - the FDA gastroenterology and urology 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 Tag Medical Products devices

FDA 510(k) Submission Details - K020705

510(k) Number K020705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2002
Decision Date April 26, 2002
Days to Decision 53 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 130d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OTN Device Classification - Class 2, Special Controls

Product Code OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Surgical Treatment Of Female Stress Urinary Incontinence Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

All 36
Devices cleared under the same product code (OTN) and FDA review panel - the closest regulatory comparables to K020705.
BIOARC SP SLING KIT
K030123 · American Medical Systems, Inc. · Feb 2003
MONARC SLING SYSTEM
K023516 · American Medical Systems, Inc. · Nov 2002
MODIFICATION TO SPARC SLING SYSTEM
K021263 · American Medical Systems, Inc. · May 2002
MODIFICATION TO TRELEX MESH SURGICAL MESH
K020110 · Boston Scientific · Apr 2002
MODIFICATION TO SPARC SLING SYSTEM
K020663 · American Medical Systems, Inc. · Mar 2002
SPARC SLING SYSTEM
K013355 · American Medical Systems, Inc. · Oct 2001