Cleared Traditional

K123028 - VERTESSA LITE 10 X20CM

K123028 is the FDA 510(k) clearance for VERTESSA LITE 10 X20CM by Caldera Medical, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code OTO) cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K123028 · Caldera Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
209d
Days
Class 2
Risk

K123028 is an FDA 510(k) clearance for the VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (product code OTO), Class II - Special Controls.

Submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on April 25, 2013 after a review of 209 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 878.3300 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Caldera Medical, Inc. devices

Submission Details

510(k) Number K123028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2012
Decision Date April 25, 2013
Days to Decision 209 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 160d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Bridging Material To Attach The Vaginal Apex To The Anterior Longitudinal Ligament Of The Sacrum; Procedures Include Abdominal Sacrocolpopexy And Laparoscopic Sacrocolpopexy.
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

All 13
Devices cleared under the same product code (OTO) and FDA review panel - the closest regulatory comparables to K123028.
Polyform Synthetic Mesh
K171271 · Boston Scientific Corporation · Dec 2017
RESTORELLE Y CONTOUR MESH
K140116 · Coloplast A/S · Feb 2014
RESTORELLE M, RESTORELLE XL
K132061 · Coloplast Corp. · Aug 2013
RESTORELLE Y CONTOUR
K123914 · Coloplast A/S · Mar 2013
UPSYLON Y MESH
K122794 · Boston Scientific Corp · Dec 2012
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
K122968 · Coloplast Corp. · Dec 2012