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510(k) K232003

Endoscopic Video Image Processor, Single-Use Video Hysteroscope by Guangzhou Red Pine Medical Instrument Co., Ltd. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2024
Date Received
July 6, 2023
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 Guangzhou Red Pine Medical Instrument Co., Ltd.

  • K251951 — Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, (December 16, 2025)
  • K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (August 8, 2025)
  • K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F) (February 7, 2025)
  • K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) (August 2, 2024)
  • K241500 — Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cys (July 12, 2024)
  • K240663 — Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) (June 21, 2024)
  • K232043 — Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, (February 16, 2024)
  • K221158 — Single-Use Video Flexible Ureterorenoscope System (March 6, 2023)

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