Ureterorenoscope System
FDA 510(k) K180367 · Shanghai AnQing Medical Instrument Co., Ltd.
510(k) numberK180367
Submission
- Device name
- Ureterorenoscope System
- Applicant
- Shanghai AnQing Medical Instrument Co., Ltd.
Shanghai, CN - Received
- February 12, 2018
- Decision date
- July 3, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGB – Ureteroscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code FGB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9…FGB · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 09/09/2026SE |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | Boston Scientific Corporation | 08/26/2026SE |
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGB · Special | Scivita Medical Technology Co., Ltd. | 08/14/2026SE |
| K253505 | Zamenix PFGB · Traditional | Roen Surgical, Inc. | 08/07/2026SE |
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR…FGB · Traditional | MacroLux Medical Technology Co., Ltd. | 07/20/2026SE |
| K252929 | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model…FGB · Traditional | Anhui Happiness Workshop Instruments Co., Ltd. | 04/09/2026SE |
| K260013 | CVAC Image ProcessorFGB · Traditional | Calyxo, Inc. | 03/06/2026SE |
| K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible…FGB · Traditional | Zhejiang Geyi Medical Instrument Co., Ltd. | 12/16/2025SE |
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9…FGB · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 12/16/2025SE |
| K253411 | Miniature Telescope for Urology (27033AA)FGB · Traditional | Karl Storz SE & CO. KG | 11/18/2025SE |
More from Karl Storz SE & CO. KG
| 510(k) | Device | Decision |
|---|---|---|
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23)HIH · Traditional | 02/26/2026SE |
| K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US…FGB · Special | 10/03/2025SE |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJ · Special | 09/15/2025SE |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)EOQ · Traditional | 08/27/2025SE |
| K243497 | Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US…EOQ · Traditional | 05/29/2025SE |
| K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)FGB · Traditional | 04/11/2025SE |
| K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)FBN · Traditional | 10/17/2023SE |
| K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJ · Traditional | 11/09/2022SE |
| K222737 | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)FGB · Special | 10/05/2022SE |
| K220159 | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model:…FGB · Traditional | 08/26/2022SE |
Questions and answers
When was Ureterorenoscope System cleared by the FDA?
Ureterorenoscope System (K180367) received a 510(k) decision of Substantially Equivalent on July 3, 2018, 141 days after the submission was received.
What is the product code of K180367?
The FDA product code is FGB – Ureteroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.