510(k) K231878
- Device
- Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
- Applicant
- STERIS Corporation
- 510(k) number
- K231878
- Product code
- FGB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-07-25
- Date received
- 2023-06-26
- Regulation
- 876.1500
- Classification name
- Ureteroscope And Accessories, Flexible/Rigid
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Carroll Martin
- Address
- 5976 Heisley Rd. Mentor OH US 44060 44060
FDA Registration Numbers
- 3002808148
- 2242464
- 1825146
- 3004040397
- 3015540957
- 2183744
- 3006546082
- 1037955
- 3028058843
- 3011050570
- 3012797688
- 3010202439
- 3005465238
- 1820334
- 3013992977
- 3005099803
- 8010298
- 3003923762
- 3017210488
- 8010487
- 3002807314
- 3003915875
- 1418479
- 9611612
- 3040391040
- 3004361445
- 3013687468
- 3003206812
- 1828132
- 3009453258
- 3014498758
- 1519132
- 3037966040
- 3009171251
- 3032959393
- 3016690337
- 3008439484
- 3014279513
- 1000484830
- 8043903
- 3011986317
- 3009134855
- 3003782610
- 9616693
- 2936485
- 3038613058
- 3033010858
- 3021246306
- 3012375451
- 3003542872
- 3014342096
- 3008998256
- 3025349506
- 1319639
- 8010418
- 9610691
- 3016045249
- 3012322232
- 3015925378
- 3025318945
- 3012843412
- 9611102
- 3038296436
- 3015139943
- 3023809956
- 9615001
- 3008386005
- 2030624
- 2531475
- 3023460764
- 3005941719
- 3022106566
- 3024021261
- 3005580113
- 3020369549
- 3015970743
- 3036978610
- 1221826
- 3014615697
- 3010273872
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code FGB
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) | Boston Scientific Corporation | 2025-09-24 |
| K250049 | Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) | Seplou (Zhuhai) Co., Ltd. | 2025-08-26 |
| K243550 | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | Karl Storz SE & CO. KG | 2025-06-06 |
| K242699 | Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) | Opcom Medical, Inc. | 2025-05-28 |
| K250785 | Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 2025-05-06 |
| K243894 | F88 URE-SD/RD Flexible Ureteroscope | Sg Endoscopy Pte, Ltd. | 2025-05-02 |
| K243532 | LumiRex Ureteroscope | Contra Healthcare Solutions, LLC | 2025-04-28 |
| K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-04-11 |