Cleared Special

K033691 - SAFYRE VS AND SAFYRE T

K033691 is an FDA 510(k) clearance for SAFYRE VS AND SAFYRE T, manufactured by Promedon. The device is a Class 2 Gastroenterology & Urology device with product code OTN cleared through the Special 510(k) pathway after a 25-day FDA review.

K033691 · Promedon · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
25d
Days
Class 2
Risk

K033691 is an FDA 510(k) clearance for the SAFYRE VS AND SAFYRE T. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN), Class II - Special Controls.

Submitted by Promedon (Hopkonton, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 25 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. 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 Promedon devices

FDA 510(k) Submission Details - K033691

510(k) Number K033691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2003
Decision Date December 19, 2003
Days to Decision 25 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 130d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K033691.
URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
K041176 · Sofradim Production · May 2004
MODIFICATION TO SURGICAL MESH POLYMERIC
K040787 · Boston Scientific · Apr 2004
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
K040538 · American Medical Systems, Inc. · Mar 2004
GYNECARE TVT OBTURATOR SYSTEM
K033568 · Ethicon, Inc. · Dec 2003
MENTOR OBTAPE TRANS-OBTURATOR TAPE
K031767 · Mentor Corp. · Jul 2003
BIOARC SP SLING KIT
K030123 · American Medical Systems, Inc. · Feb 2003