HOPKINS Telescopes
FDA 510(k) K223885 · Karl Storz Endoscopy America, Inc.
510(k) numberK223885
Submission
- Device name
- HOPKINS Telescopes
- Applicant
- Karl Storz Endoscopy America, Inc.
El Segundo, CA, US - Received
- December 27, 2022
- Decision date
- September 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIH – Hysteroscope (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1690
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K254294 | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A…HIH · Traditional | Zhejiang Geyi Medical Instrument Co., Ltd. | 09/08/2026SE |
| K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)HIH · Traditional | Axora Medical, Inc. | 08/18/2026SE |
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| K254050 | Manual Tissue Removal DeviceHIH · Traditional | Suzhou AcuVu Medical Technology Co., Ltd. | 05/15/2026SE |
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23)HIH · Traditional | Shanghai AnQing Medical Instrument Co., Ltd. | 02/26/2026SE |
| K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope…HIH · Traditional | Jiangsu Jiyuan Medical Technology Co., Ltd. | 12/18/2025SE |
| K252012 | SPY Cystoscope/HysteroscopeHIH · Special | Stryker Endoscopy | 07/18/2025SE |
| K243382 | RZ Resectoscope SystemHIH · Traditional | Rz Medizintechnik GmbH | 06/03/2025SE |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…HIH · Traditional | MacroLux Medical Technology Co., Ltd. | 08/16/2024SE |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)HIH · Special | Guangzhou Red Pine Medical Instrument Co., Ltd. | 08/02/2024SE |
More from Guangzhou Red Pine Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and AccessoriesEQN · Traditional | 05/15/2026SE |
| K240506 | KARL STORZ HoldersOCV · Traditional | 10/22/2024SE |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP)…GCJ · Traditional | 06/23/2023SE |
| K223520 | UNIDRIVE SIII SystemHIH · Traditional | 04/27/2023SE |
| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional | 03/17/2023SE |
| K221004 | HOPKINS TelescopesGCJ · Traditional | 12/20/2022SE |
| K222504 | H1GCJ · Traditional | 11/10/2022SE |
| K213194 | HD MediastinoscopeEWY · Traditional | 06/23/2022SE |
| K221174 | Telepack +FET · Special | 05/13/2022SE |
Questions and answers
When was HOPKINS Telescopes cleared by the FDA?
HOPKINS Telescopes (K223885) received a 510(k) decision of Substantially Equivalent on September 14, 2023, 261 days after the submission was received.
What is the product code of K223885?
The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.