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510(k) K123028

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

K123028 is an FDA 510(k) premarket notification submitted by Caldera Medical, Inc. for the device "VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH". The FDA issued a decision of Substantially Equivalent on April 25, 2013. The device falls under product code OTO (Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed), a Class II device regulated under 21 CFR 878.3300. Caldera Medical, Inc. has at least 10 other 510(k) clearances on record.

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.

Other clearances by Caldera Medical, Inc.

  • K233500 — Benesta Tissue Removal Device (November 30, 2023)
  • K211975 — Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, (November 10, 2021)
  • K192811 — BenestaTM Tissue Removal Device (October 23, 2020)
  • 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)
  • K150016 — Vertessa Lite (April 6, 2015)
  • K150023 — Vertessa Lite Y-Mesh (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)
  • K122968 — NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 (December 18, 2012)
  • K122794 — UPSYLON Y MESH (December 18, 2012)
  • K122440 — RESTORELLE L (November 19, 2012)

FDA data resources