Cleared Traditional

K123028 - VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K123028 · Caldera Medical, Inc. · Obstetrics & Gynecology device
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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.