510(k) K201897
- Device
- Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525
- Applicant
- Richard Wolf Medical Instruments Corporation
- 510(k) number
- K201897
- Product code
- FGB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-01-15
- Date received
- 2020-07-08
- Regulation
- 876.1500
- Classification name
- Ureteroscope And Accessories, Flexible/rigid
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michael Loiterman
- Address
- 353 Corporate Woods Pkwy. Vernon Hills IL US 60061 60061
FDA Registration Numbers#
- 3005941719
- 3000160970
- 3015925378
- 1221826
- 1000121056
- 3003206812
- 3014279513
- 2020550
- 3035710892
- 9611612
- 3012843412
- 3030504644
- 9610877
- 9610691
- 1319639
- 3005173255
- 2531475
- 3015540957
- 8010487
- 2183744
- 3042940358
- 8010298
- 3020746799
- 9611102
- 3011642792
- 3033010858
- 3036978610
- 3006546082
- 1820334
- 3010419931
- 3008439484
- 3023460764
- 3014342096
- 3029929134
- 9615001
- 3010421104
- 9610773
- 3004361445
- 3009453258
- 3020369549
- 3035484431
- 1825146
- 3008386005
- 3032578846
- 3017961114
- 3023809956
- 3032429484
- 3017425975
- 3003782610
- 9616693
- 3008998256
- 9681260
- 3037966040
- 3008776287
- 9614434
- 3017367014
- 3002807314
- 1828132
- 3016045249
- 3021031769
- 3010202439
- 3004111573
- 1000484830
- 3003542872
- 3015139943
- 8043903
- 3003923762
- 3014498758
- 3005099803
- 3012375451
- 3015970743
- 3004644065
- 3003915875
- 3012322232
- 3028058843
- 3005580113
- 3038613058
- 3016881508
- 2030624
Source Documents#
Other 510(k) Records For Product Code FGB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262437 | Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A) | Zhejiang Geyi Medical Instrument Co., Ltd. | 2026-10-29 |
| K260708 | Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection) | Vein 360 | 2026-10-20 |
| K261447 | CVAC® Aspiration System | Calyxo, Inc. | 2026-09-15 |
| K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2026-09-09 |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope System | Boston Scientific Corporation | 2026-08-26 |
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | Scivita Medical Technology Co., Ltd. | 2026-08-14 |
| K253505 | Zamenix™ P | Roen Surgical, Inc. | 2026-08-07 |
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) | MacroLux Medical Technology Co., Ltd. | 2026-07-20 |
| K252929 | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) | Anhui Happiness Workshop Instruments Co., Ltd. | 2026-04-09 |
| K260013 | CVAC Image Processor | Calyxo, Inc. | 2026-03-06 |
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-12-16 |
| K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) | Zhejiang Geyi Medical Instrument Co., Ltd. | 2025-12-16 |
| K253411 | Miniature Telescope for Urology (27033AA) | Karl Storz SE & CO. KG | 2025-11-18 |
| K250917 | Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) | Shenzhen Sanping Image Technology Co., Ltd. | 2025-10-31 |
| K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-10-03 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases