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510(k) K141515

AED HYSTEROSCOPE AND ACCESSORIES by National Advanced Endoscopy Devices, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2015
Date Received
June 9, 2014
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 National Advanced Endoscopy Devices, Inc.

  • K170285 — AED Sinuscope (August 1, 2017)
  • K102663 — AED RESECTOSCOPE (December 30, 2010)
  • K081553 — AED BIPOLAR FORCEPS, MODEL 13-1646 (September 29, 2008)
  • K081503 — AED MONOPOLAR LAP ACCESSORIES (September 25, 2008)
  • K993689 — AED CYSTOSCOPE (December 15, 1999)
  • K993688 — AED LAPAROSCOPE (December 6, 1999)
  • K991656 — AED ARTHROSCOPE (December 2, 1999)

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  • K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, H (August 16, 2024)
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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)
  • K232003 — Endoscopic Video Image Processor, Single-Use Video Hysteroscope (February 12, 2024)