510(k) K123028

VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH by Caldera Medical, Inc. — Product Code OTO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 25, 2013
Date Received: September 28, 2012
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class: Class II
Regulation Number: 878.3300
Review Panel: OB
Submission Type

Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.

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K192822 — Benesta Hysteroscope (September 9, 2020)
K193603 — Benesta Medical Sterilization Tray (July 20, 2020)
K191416 — Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sli (February 7, 2020)
K172614 — Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transob (May 4, 2018)
K162201 — Desara TV, Desara Blue TV (January 11, 2017)
K150023 — Vertessa Lite Y-Mesh (April 6, 2015)
K150016 — Vertessa Lite (April 6, 2015)

Other clearances for product code OTO

K171271 — Polyform Synthetic Mesh (December 15, 2017)
K150016 — Vertessa Lite (April 6, 2015)
K150023 — Vertessa Lite Y-Mesh (April 6, 2015)
K140116 — RESTORELLE Y CONTOUR MESH (February 12, 2014)
K132061 — RESTORELLE M, RESTORELLE XL (August 2, 2013)
K123914 — RESTORELLE Y CONTOUR (March 5, 2013)
K123337 — VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM (February 21, 2013)
K122794 — UPSYLON Y MESH (December 18, 2012)
K122968 — NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 (December 18, 2012)
K122440 — RESTORELLE L (November 19, 2012)