Cleared Traditional

K121928 - DESARA SL

K121928 is an FDA 510(k) clearance for DESARA SL, manufactured by Caldera Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OTN cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K121928 · Caldera Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
232d
Days
Class 2
Risk

K121928 is an FDA 510(k) clearance for the DESARA SL. 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. (Agoura Hills, US). The FDA issued a Cleared decision on February 19, 2013 after a review of 232 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. 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Caldera Medical, Inc. devices

FDA 510(k) Submission Details - K121928

510(k) Number K121928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2012
Decision Date February 19, 2013
Days to Decision 232 days
Submission Type Traditional
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
101d slower than avg
Panel avg: 131d · This submission: 232d
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 52
Devices cleared under the same product code (OTN) and FDA review panel - the closest regulatory comparables to K121928.
RETROARC RETROPUBIC SLING SYSTEM
K132655 · American Medical Systems, Inc. · Nov 2013
DESARA MESH, DESARA BLUE
K132069 · Caldera Medical, Inc. · Sep 2013
GYNECARE TVT EXACT CONTINENCE SYSTEM
K132054 · Ethicon, Inc. · Aug 2013
BLUE SUI SLING
K121754 · Boston Scientific Corp · Oct 2012
DESARA MESH
K112609 · Caldera Medical, Inc. · Sep 2011
GMD UNIVERSAL URINARY INCONTINENCE SLING
K111219 · Generic Medical Device, Inc. · Jun 2011