FGB · Ureteroscope And Accessories, Flexible/Rigid

Device class

Class II

Regulation 876.1500

Total clearances

2020-07-24 → 2026-09-15

Last 12 months

Unique sponsors

Definition

What is Ureteroscope And Accessories, Flexible/Rigid

To perform various diagnostic and therapeutic 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).

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

Regulation number

876.1500

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Hunan Vathin Medical Instrument Co., Ltd.	5	0	2025-05-06
Shanghai AnQing Medical Instrument Co., Ltd.	5	0	2025-10-03
Karl Storz SE & CO. KG	4	1	2025-11-18
Boston Scientific Corporation	4	1	2026-08-26
STERIS Corporation	3	0	2023-07-25
Guangzhou Red Pine Medical Instrument Co., Ltd.	3	2	2026-09-09
MacroLux Medical Technology Co., Ltd.	2	1	2026-07-20
Scivita Medical Technology Co., Ltd.	2	1	2026-08-14
Huger Medical Instrument Co., Ltd.	2	0	2024-07-01
Calyxo, Inc.	2	2	2026-09-15
Ambu A/S	2	0	2024-08-16
Sg Endoscopy Pte, Ltd.	1	0	2025-05-02
Auris Health, Inc.	1	0	2022-04-29
Contra Healthcare Solutions, LLC	1	0	2025-04-28
Dyne Medical Group, Inc.	1	0	2024-09-05
Hunan Endoso Life Technology Co., Ltd.	1	0	2025-01-22
Seplou (Zhuhai) Co., Ltd.	1	0	2025-08-26
Roen Surgical, Inc.	1	1	2026-08-07
Shenzhen HugeMed Medical Technical Development Co., Ltd.	1	0	2024-05-10
Zhuhai Pusen Medical Technology Co., Ltd.	1	0	2024-07-16
Boston Scientific Corporation -	1	0	2023-12-12
Shanghai SeeGen Photoelectric Technology Co., Ltd.	1	0	2022-02-22
Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi	1	0	2024-08-16
Gyrus Acmi, Inc.	1	0	2024-03-25
Karl Storz Endovision, Inc.	1	0	2024-06-10

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.

Code	Type	Description	Confidence	Rationale
52353	CPT	—	High	Cystourethroscopy with manipulation of ureteral calculus; ureteroscope used
52356	CPT	—	High	Cystourethroscopy with transurethral resection of bladder tumor via ureteroscope
50957	CPT	—	Medium	Ureteral endoscopy through existing ureterostomy

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-15	K261447	Calyxo, Inc.	CVAC® Aspiration System
2026-09-09	K262488	Guangzhou Red Pine Medical Instrument Co., Ltd.	Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
2026-08-26	K261153	Boston Scientific Corporation	LithoVue Elite Digital Flexible Ureteroscope System
2026-08-14	K262552	Scivita Medical Technology Co., Ltd.	Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
2026-08-07	K253505	Roen Surgical, Inc.	Zamenix P
2026-07-20	K260516	MacroLux Medical Technology Co., Ltd.	BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
2026-04-09	K252929	Anhui Happiness Workshop Instruments Co., Ltd.	Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
2026-03-06	K260013	Calyxo, Inc.	CVAC Image Processor
2025-12-16	K252468	Zhejiang Geyi Medical Instrument Co., Ltd.	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)
2025-12-16	K251951	Guangzhou Red Pine Medical Instrument Co., Ltd.	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)
2025-11-18	K253411	Karl Storz SE & CO. KG	Miniature Telescope for Urology (27033AA)
2025-10-31	K250917	Shenzhen Sanping Image Technology Co., Ltd.	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)
2025-10-03	K252806	Shanghai AnQing Medical Instrument Co., Ltd.	Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
2025-09-24	K252703	Boston Scientific Corporation	LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)
2025-08-26	K250049	Seplou (Zhuhai) Co., Ltd.	Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)
2025-06-06	K243550	Karl Storz SE & CO. KG	KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
2025-05-28	K242699	Opcom Medical, Inc.	Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)
2025-05-06	K250785	Hunan Vathin Medical Instrument Co., Ltd.	Single-use Flexible Ureteroscope
2025-05-02	K243894	Sg Endoscopy Pte, Ltd.	F88 URE-SD/RD Flexible Ureteroscope
2025-04-28	K243532	Contra Healthcare Solutions, LLC	LumiRex Ureteroscope
2025-04-11	K243857	Shanghai AnQing Medical Instrument Co., Ltd.	Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)
2025-03-27	K243708	Scivita Medical Technology Co., Ltd.	Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)
2025-02-11	K243155	Dongguan Zsr Biomedical Technology Company Limited	Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
2025-01-29	K243117	Hunan Vathin Medical Instrument Co., Ltd.	Digital Video Processor
2025-01-22	K241956	Hunan Endoso Life Technology Co., Ltd.	Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)