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
6
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 1 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
OTU Medical, Inc. 2 0 2023-09-29
Olympus Medical Systems Corporation 2 0 2023-01-20
Shanghai AnQing Medical Instrument Co., Ltd. 2 0 2025-09-15
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
Medimaging Integrated Solution, Inc (Miis) 1 0 2023-10-06
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
Karl Storz Endoscopy America, Inc. 1 0 2021-09-03
MacroLux Medical Technology Co., Ltd. 1 0 2024-06-10
Medivators, Inc. 1 0 2023-03-01
Shenzhen HugeMed Medical Technical Development Co., Ltd. 1 0 2023-11-13
Strauss Surgical USA 1 1 2026-04-16
Zenflow, Inc. 1 0 2025-09-23
KARL STORZ Endoscopy-America, Inc. 1 0 2020-10-29
Karl Storz SE & CO. KG 1 0 2025-08-13
Uvision360, Inc. 1 0 2021-06-30
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