Cleared Special

K072456 - DESARA MESH SLING, MODEL CAL-DS01

K072456 is an FDA 510(k) clearance for DESARA MESH SLING, manufactured by Caldera Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OTN cleared through the Special 510(k) pathway after a 251-day FDA review.

K072456 · Caldera Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
251d
Days
Class 2
Risk

K072456 is an FDA 510(k) clearance for the DESARA MESH SLING, MODEL CAL-DS01. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN), Class II - Special Controls.

Submitted by Caldera Medical, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on May 8, 2008 after a review of 251 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072456

510(k) Number K072456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2007
Decision Date May 08, 2008
Days to Decision 251 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 131d · This submission: 251d
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 65
Devices cleared under the same product code (OTN) and FDA review panel - the closest regulatory comparables to K072456.
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ALIGN URETHRAL SUPPORT SYSTEM
K070073 · C.R. Bard, Inc. · Mar 2007
AMS SMART SLING SYSTEM
K063713 · American Medical Systems, Inc. · Feb 2007
K072456 · DESARA MESH SLING, MODEL CAL-DS01
Download PDF FDA Summary Caldera Medical, Inc.