MICRO-6-SERIES (MR-6, MR-6L) Ureteroscopes, MRO-6 Series (MR-633, MR-642) Ureteroscopes, MRO-7 Series (MRO-733) Ureteros
FDA 510(k) K011849 · Circon Video
510(k) numberK011849
Submission
- Device name
- MICRO-6-SERIES (MR-6, MR-6L) Ureteroscopes, MRO-6 Series (MR-633, MR-642) Ureteroscopes, MRO-7 Series (MRO-733) Ureteros
- Applicant
- Circon Video
Santa Barbara, CA, US - Received
- June 13, 2001
- Decision date
- December 10, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K012758 | Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models…FGB · Traditional | 04/09/2002SE |
| K011876 | Dolphin II Fluid Management System, Model DOL-2HIG · Traditional | 01/08/2002SE |
| 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 MICRO-6-SERIES (MR-6, MR-6L) Ureteroscopes, MRO-6 Series (MR-633, MR-642) Ureteroscopes, MRO-7 Series (MRO-733) Ureteros cleared by the FDA?
MICRO-6-SERIES (MR-6, MR-6L) Ureteroscopes, MRO-6 Series (MR-633, MR-642) Ureteroscopes, MRO-7 Series (MRO-733) Ureteros (K011849) received a 510(k) decision of Substantially Equivalent on December 10, 2001, 180 days after the submission was received.
What is the product code of K011849?
The FDA product code is FGB – Ureteroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.