Chrysalis Intelligence · Product Codes · FAJ

FAJ · Cystoscope And Accessories, Flexible/Rigid

Gastroenterology, Urology · 37 clearances · 23 unique sponsors

Device class
Class II
Regulation 876.1500
Total clearances
37
2020-04-02 → 2026-05-21
Last 12 months
9
Unique sponsors
23
Definition

What is Cystoscope And Accessories, Flexible/Rigid

To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.1500
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Uroviu Corporation 5 2 2025-10-23
Ambu A/S 4 0 2025-06-11
Guangzhou Red Pine Medical Instrument Co., Ltd. 3 0 2025-08-08
Hunan Vathin Medical Instrument Co., Ltd. 2 0 2024-12-18
Shanghai AnQing Medical Instrument Co., Ltd. 2 1 2025-09-15
Olympus Medical Systems Corporation 2 0 2023-01-20
OTU Medical, Inc. 2 0 2023-09-29
American Medical Endoscopy, Inc. 2 1 2026-03-27
Verathon Medical (Canada) Ulc 1 1 2026-05-11
Cogentix Medical, Inc. 1 1 2026-04-07
Olympus Winter & Ibe GmbH 1 1 2026-05-21
Zhuhai Pusen Medical Technology Co., Ltd. 1 0 2022-09-26
Lina Medical Aps 1 0 2024-08-22
Medimaging Integrated Solution, Inc (Miis) 1 0 2023-10-06
Karl Storz Endoscopy America, Inc. 1 0 2021-09-03
MacroLux Medical Technology Co., Ltd. 1 0 2024-06-10
Strauss Surgical USA 1 1 2026-04-16
Zenflow, Inc. 1 1 2025-09-23
Uvision360, Inc. 1 0 2021-06-30
Medivators, Inc. 1 0 2023-03-01
KARL STORZ Endoscopy-America, Inc. 1 0 2020-10-29
Karl Storz SE & CO. KG 1 0 2025-08-13
Shenzhen HugeMed Medical Technical Development Co., Ltd. 1 0 2023-11-13
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
52000 CPT High CPT code for cystourethroscopy with any urological procedure including biopsy
52204 CPT Medium CPT code for cystourethroscopy with biopsy(ies)
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-21 K260649 Olympus Winter & Ibe GmbH 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,
2026-05-11 K253696 Verathon Medical (Canada) Ulc CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)
2026-04-16 K253892 Strauss Surgical USA 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°,
2026-04-07 K253905 Cogentix Medical, Inc. PrimeSight UltraView System
2026-03-27 K260271 American Medical Endoscopy, Inc. Strauss Surgical cystoscope, hysteroscope and accessories Instruments
2025-10-23 K253226 Uroviu Corporation UV5000W Handle
2025-09-23 K251140 Zenflow, Inc. Zenflow Spring Scope
2025-09-15 K252598 Shanghai AnQing Medical Instrument Co., Ltd. Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
2025-09-11 K250797 Uroviu Corporation UV5000 Handle
2025-08-13 K243653 Karl Storz SE & CO. KG KARL STORZ HOPKINS Telescopes for Urology
2025-08-08 K252176 Guangzhou Red Pine Medical Instrument Co., Ltd. Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
2025-08-01 K251652 American Medical Endoscopy, Inc. 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
2025-06-11 K250269 Ambu A/S Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)
2024-12-18 K242535 Hunan Vathin Medical Instrument Co., Ltd. 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)
2024-12-13 K243196 Uroviu Corporation Uro-G HD Cystoscope (1520)
2024-10-16 K240849 Ambu A/S Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2
2024-10-10 K240848 Ambu A/S Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance
2024-08-22 K240227 Lina Medical Aps LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)
2024-07-12 K241500 Guangzhou Red Pine Medical Instrument Co., Ltd. Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
2024-06-21 K240663 Guangzhou Red Pine Medical Instrument Co., Ltd. Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
2024-06-10 K240283 MacroLux Medical Technology Co., Ltd. BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)
2024-06-07 K232837 Uroviu Corporation Uro-G HD Flexible Cystoscope
2023-11-13 K231118 Shenzhen HugeMed Medical Technical Development Co., Ltd. Cystoscope System
2023-10-06 K223926 Medimaging Integrated Solution, Inc (Miis) VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
2023-09-29 K231702 OTU Medical, Inc. WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet