510(k) K202957
- Device
- Flexible Video Cysto-Urethroscope (C-view)
- Applicant
- KARL STORZ Endoscopy-America, Inc
- 510(k) number
- K202957
- Product code
- FAJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-10-29
- Date received
- 2020-09-30
- Regulation
- 876.1500
- Classification name
- Cystoscope 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
- No
Applicant Contact#
- Contact
- Winkie Wong
- Address
- 2151 E. Grand Ave. El Segundo CA US 90245 90245
FDA Registration Numbers#
- 3003687489
- 3015139943
- 3011459664
- 3025349506
- 3012649202
- 3035710892
- 3029929134
- 1825146
- 3015316279
- 3004215117
- 2431166
- 9610617
- 8010047
- 3005580113
- 3005382983
- 3014615697
- 3004644065
- 3012536737
- 9515015
- 3004111573
- 3007710604
- 3013992977
- 3010400865
- 3003637092
- 1650907
- 2030624
- 1724474
- 3010399422
- 3033589330
- 8010418
- 3012797688
- 3015042209
- 3037966040
- 3010220595
- 3014211785
- 1064858
- 3010707607
- 3015895045
- 2183744
- 9615001
- 3003782610
- 9610877
- 9610773
- 8010349
- 3012375451
- 3015309643
- 1833700
- 3011050570
- 9680515
- 3010419931
- 3029981244
- 2518897
- 9610691
- 3016678045
- 3020369549
- 8043903
- 3010398867
- 1820334
- 1219930
- 3003915875
- 3036978610
- 3016881508
- 1418479
- 3016045249
- 3040391040
- 9611503
- 3012843412
- 3003790304
- 2531475
- 9610595
- 2085947
- 3003990090
- 1526611
- 3004040397
- 3013557562
- 1651395
- 3022631687
- 3006789154
- 3007829657
- 3010202439
Source Documents#
Other 510(k) Records For Product Code FAJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, | Olympus Winter & Ibe GmbH | 2026-05-21 |
| K253696 | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) | Verathon Medical (Canada) Ulc | 2026-05-11 |
| K253905 | PrimeSight UltraView System | Cogentix Medical, Inc. | 2026-04-07 |
| K260271 | Strauss Surgical cystoscope, hysteroscope and accessories Instruments | American Medical Endoscopy, Inc. | 2026-03-27 |
| K253226 | UV5000W Handle | Uroviu Corporation | 2025-10-23 |
| K251140 | Zenflow Spring Scope | Zenflow, Inc. | 2025-09-23 |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-09-15 |
| K250797 | UV5000 Handle | Uroviu Corporation | 2025-09-11 |
| K243653 | KARL STORZ HOPKINS Telescopes for Urology | Karl Storz SE & CO. KG | 2025-08-13 |
| K252176 | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-08-08 |
| K251652 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo | American Medical Endoscopy, Inc. | 2025-08-01 |
| K250269 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) | Ambu A/S | 2025-06-11 |
| K242535 | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-12-18 |
| K243196 | Uro-G HD Cystoscope (1520) | Uroviu Corporation | 2024-12-13 |
| K240849 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 | Ambu A/S | 2024-10-16 |
Legacy Summary#
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FDA Review#
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