510(k) K941013
- Device
- HMT ALEXCOPE
- Applicant
- SERVICETRENDS, INC.
- 510(k) number
- K941013
- Product code
- FGB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-02-09
- Date received
- 1994-03-03
- 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
- JOHN WARLICK
- Address
- 2130 Barrett Park Dr. NE, Suite 103 Kennesaw GA US 30144 30144
FDA Registration Numbers#
- 3025349506
- 3013247477
- 8010047
- 3042940358
- 3029981244
- 8010298
- 1000484830
- 3012322232
- 3019807891
- 2531475
- 9616693
- 3010707607
- 9610773
- 1418479
- 3033010858
- 3022106566
- 3003782610
- 3008439484
- 3035484431
- 3004111573
- 3002808148
- 9611612
- 2936485
- 9614434
- 3011986317
- 9610877
- 3028058843
- 3024021261
- 3008998256
- 1221826
- 3020369549
- 3011050570
- 3003542872
- 9610617
- 1000121056
- 3014683069
- 3013992977
- 1820334
- 3010202439
- 3037966040
- 9610691
- 8043903
- 3010273872
- 8010487
- 3004361445
- 1037955
- 3014498758
- 3014615697
- 3010421104
- 3009171251
- 3005099803
- 3005465238
- 9610595
- 1319639
- 3032959393
- 3009134855
- 1519132
- 3017961114
- 9615001
- 3005173255
- 3021246306
- 3032578846
- 3004644065
- 9611102
- 3023809956
- 3015970743
- 2030624
- 3038613058
- 3017425975
- 2124215
- 3030504644
- 3009453258
- 3017210488
- 3008776287
- 3035710892
- 3015925378
- 8010418
- 3014893827
- 3036978610
Source Documents#
Other 510(k) Records For Product Code FGB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
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