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510(k) K192822

Benesta Hysteroscope by Caldera Medical, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2020
Date Received
October 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

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  • K192811 — BenestaTM Tissue Removal Device (October 23, 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)

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  • K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, H (August 16, 2024)
  • K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) (August 2, 2024)
  • K240401 — ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS- (July 26, 2024)
  • K231260 — HTx Disposable Hysteroscope System (March 5, 2024)
  • K233635 — SPY Cystoscope/Hysteroscope (February 12, 2024)
  • K232003 — Endoscopic Video Image Processor, Single-Use Video Hysteroscope (February 12, 2024)