Schoelly Cystoscopes/Hysteroscopes and Accessories
FDA 510(k) K150158 · Schoelly Fiberoptic GmbH
510(k) numberK150158
Submission
- Device name
- Schoelly Cystoscopes/Hysteroscopes and Accessories
- Applicant
- Schoelly Fiberoptic GmbH
Denzlingen, DE - Received
- January 23, 2015
- Decision date
- March 9, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- HIH – Hysteroscope (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1690
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K253020 | Strauss Surgical Resection InstrumentsHIH · Traditional | American Medical Endoscopy, Inc. | 06/04/2026SE |
| 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 |
|---|---|---|
| K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…GCJ · Traditional | 06/20/2024SE |
| K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…GCJ · Traditional | 02/23/2023SE |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional | 03/12/2021SE |
| K201970 | Schoelly Cystoscopes/Hysteroscopes and AccessoriesHIH · Traditional | 10/08/2020SE |
| K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetFGA · Traditional | 02/09/2016SE |
| K143673 | CMOS Video Nasopharyngoscope SystemEOB · Special | 03/04/2015SE |
| K142249 | Schoelly SinuscopeEOB · Traditional | 01/27/2015SE |
| K143221 | Schoelly LaparoscopeGCJ · Special | 12/05/2014SE |
| K132009 | Cmos Video Nasopharyngoscope SystemEOB · Traditional | 04/09/2014SE |
| K992362 | Flexiscope Iq 101FET · Traditional | 08/05/1999SE |
Questions and answers
When was Schoelly Cystoscopes/Hysteroscopes and Accessories cleared by the FDA?
Schoelly Cystoscopes/Hysteroscopes and Accessories (K150158) received a 510(k) decision of Substantially Equivalent on March 9, 2015, 45 days after the submission was received.
What is the product code of K150158?
The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.