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510(k) K172614

Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left by Caldera Medical, Inc. — Product Code PWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2018
Date Received
August 31, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Device Class
Class II
Regulation Number
884.4910
Review Panel
GU
Submission Type

Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence

Other clearances by Caldera Medical, Inc.

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  • 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)
  • 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 PWJ

  • K181151 — GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System (August 10, 2018)
  • K173019 — GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GY (July 6, 2018)
  • K173162 — GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, G (June 28, 2018)
  • K172565 — Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery D (December 20, 2017)