Home / 510(k) Clearances / K240978

510(k) K240978

SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) by MacroLux Medical Technology Co., Ltd. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2024
Date Received
April 10, 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 MacroLux Medical Technology Co., Ltd.

  • K250452 — CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0 (June 2, 2025)
  • K240283 — BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-C (June 10, 2024)
  • K233779 — LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, (April 5, 2024)
  • K231774 — CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use (January 11, 2024)

Other clearances for product code HIH

  • K254251 — InnovexView (GC146-17, GC150-20, GC155-23) (February 26, 2026)
  • K252793 — ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysterosc (December 18, 2025)
  • K252012 — SPY Cystoscope/Hysteroscope (July 18, 2025)
  • K243382 — RZ Resectoscope System (June 3, 2025)
  • 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)
  • K233500 — Benesta Tissue Removal Device (November 30, 2023)