Home / 510(k) Clearances / K223885

510(k) K223885

HOPKINS Telescopes by Karl Storz Endoscopy America, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2023
Date Received
December 27, 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

Other clearances by Karl Storz Endoscopy America, Inc.

  • K240506 — KARL STORZ Holders (October 22, 2024)
  • K230359 — KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (3 (June 23, 2023)
  • K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable (March 17, 2023)
  • K221004 — HOPKINS Telescopes (December 20, 2022)
  • K222504 — H1 (November 10, 2022)
  • K213194 — HD Mediastinoscope (June 23, 2022)
  • K221174 — Telepack + (May 13, 2022)
  • K212458 — Flexible Video-Uretero-Renoscope SSU System (January 20, 2022)
  • K212656 — Flexible Intubation Video Endoscope – Sterile (FIVE-S) (December 29, 2021)
  • K212695 — KARL STORZ ICG Imaging System (November 15, 2021)

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