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510(k) K243382

RZ Resectoscope System by Rz Medizintechnik GmbH — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2025
Date Received
October 31, 2024
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

Other clearances by Rz Medizintechnik GmbH

  • K130778 — DISCOSCOPES, CERVICAL ENDOSCOPES (April 14, 2014)
  • K082902 — RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES (December 10, 2008)

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  • 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)
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  • K233500 — Benesta Tissue Removal Device (November 30, 2023)