510(k) K982620
- Device
- MEDIVISION CYSTOSCOPE
- Applicant
- MEDIVISION SCOPE SERVICE CENTER, INC.
- 510(k) number
- K982620
- Product code
- FAJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-30
- Date received
- 1998-07-27
- Regulation
- 876.1500
- Classification name
- Cystoscope And Accessories, Flexible/rigid
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WAYNE B STERNER
- Address
- 1440 S. State College Blvd. Suite 1c Anaheim CA US 92806 92806
FDA Registration Numbers#
- 1223490
- 3029981244
- 2084346
- 1422634
- 8010047
- 3007829657
- 3006789154
- 3014211785
- 2020550
- 9680718
- 3015895045
- 3033589330
- 9611102
- 3012375451
- 3012797688
- 9611503
- 2936485
- 3009171251
- 3008386005
- 8010349
- 3003637092
- 3015042209
- 3035710892
- 1418479
- 3022631687
- 1820334
- 3010220595
- 9610773
- 3020746799
- 3010419931
- 3008693678
- 2531475
- 3014644276
- 1721676
- 3002808148
- 3004215117
- 3007710604
- 1650907
- 3006950086
- 3018094310
- 2518897
- 3012536737
- 3033902430
- 9614434
- 3005580113
- 9610877
- 3029929134
- 8010298
- 9515015
- 1651395
- 1047843
- 3007127244
- 3013992977
- 3006554912
- 3003915875
- 1724474
- 3000279801
- 1721504
- 9610691
- 3015139943
- 9615393
- 3010421104
- 8010877
- 2085947
- 3004361445
- 3006546082
- 3010398867
- 3012263546
- 3016667340
- 1825146
- 3012843412
- 9615001
- 2183744
- 8030107
- 9612074
- 3023102955
- 3014615697
- 3010314836
- 3020369549
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K253892 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°, | Strauss Surgical USA | 2026-04-16 |
| 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 |
Legacy Summary#
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FDA Review#
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