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510(k) K221557

Visera Hysterovideoscope Olympus HYF Type V by Olympus Medical Systems Corporation — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2022
Date Received
May 31, 2022
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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Other clearances for product code HIH

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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)
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  • K232003 — Endoscopic Video Image Processor, Single-Use Video Hysteroscope (February 12, 2024)