Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models MR-9, MR-9L,
FDA 510(k) K012758 · Circon Video
510(k) numberK012758
Submission
- Device name
- Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models MR-9, MR-9L,
- Applicant
- Circon Video
Santa Barbara, CA, US - Received
- August 17, 2001
- Decision date
- April 9, 2002
- 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 |
|---|---|---|
| K011876 | Dolphin II Fluid Management System, Model DOL-2HIG · Traditional | 01/08/2002SE |
| K011849 | MICRO-6-SERIES (MR-6, MR-6L) Ureteroscopes, MRO-6 Series (MR-633, MR-642) Ureteroscopes…FGB · Traditional | 12/10/2001SE |
| K012929 | Flexible Pediatric Cystoureteroscope, Model Aur- 735FAJ · Traditional | 11/19/2001SE |
| K012951 | APN-2 USA Series Flexible CholedochoscopeFGB · Traditional | 11/09/2001SE |
| K012925 | DUR-8, Models DUR-8FGB · Traditional | 11/07/2001SE |
| K012265 | Metal Halide Light Source, Models MV-9088-T, MV-9088FCW · Traditional | 10/17/2001SE |
| K012153 | Lowsley Suprapubic TractorKOB · Traditional | 09/19/2001SE |
| K011848 | Circon AEH-4 Electrohydraulic Lithotripsy ProbeFFK · Traditional | 09/11/2001SE |
| K970595 | Circon Endotek OM-4 H2O Cystometry PumpFEN · Traditional | 10/24/1997SE |
| K914883 | Circon Acmi Gen Surg Instru for Mini Invasive SurgGEI · Traditional | 01/15/1993SE |
Questions and answers
When was Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models MR-9, MR-9L, cleared by the FDA?
Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models MR-9, MR-9L, (K012758) received a 510(k) decision of Substantially Equivalent on April 9, 2002, 235 days after the submission was received.
What is the product code of K012758?
The FDA product code is FGB – Ureteroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.