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510(k) K211975

Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System by Caldera Medical, Inc. — Product Code OTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2021
Date Received
June 25, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

Other clearances by Caldera Medical, Inc.

  • K233500 — Benesta Tissue Removal Device (November 30, 2023)
  • 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)
  • K150023 — Vertessa Lite Y-Mesh (April 6, 2015)
  • K150016 — Vertessa Lite (April 6, 2015)
  • K140843 — DESARA BLUE OV, DESARA BLUE SS (July 1, 2014)

Other clearances for product code OTN

  • K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (June 29, 2023)
  • K222293 — ArcSP Suprapubic Sling System (September 21, 2022)
  • K222468 — ArcTO Transobturator Sling System (September 15, 2022)
  • K211223 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (July 21, 2021)
  • K210087 — Athena Surgical RMUS System (April 12, 2021)
  • K201686 — GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ (September 17, 2020)
  • K183134 — ArcTV Transvaginal Sling System (February 7, 2019)
  • K162201 — Desara TV, Desara Blue TV (January 11, 2017)
  • K140843 — DESARA BLUE OV, DESARA BLUE SS (July 1, 2014)
  • K131229 — SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS (December 5, 2013)