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510(k) K103418

DESARA MINI by Caldera Medical, Inc. — Product Code PAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2011
Date Received
November 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.

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  • 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)

Other clearances for product code PAH

  • K242473 — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (5 (October 18, 2024)
  • K221874 — Altis Single Incision Sling System (February 15, 2023)
  • K191416 — Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sli (February 7, 2020)
  • K121562 — ALTIS SINGLE INCISION CLING SYSTEM (November 5, 2012)
  • K123179 — AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING (November 2, 2012)
  • K121641 — MINIARC PRO SINGLE-INCISION SLING SYSTEM (September 7, 2012)
  • K110420 — OPHIRA MINI SLING SYSTEM (May 8, 2012)
  • K100807 — MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 (June 7, 2010)
  • K092607 — AJUST ADJUSTABLE SINGLE INCISION SLING (November 20, 2009)
  • K091180 — MINITAPE URETHRAL SLING (July 14, 2009)