Chrysalis Intelligence · Product Codes · FAD

FAD · Stent, Ureteral

Gastroenterology, Urology · 14 clearances · 8 unique sponsors

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Device class

Class II

Regulation 876.4620

Total clearances

14

2020-01-02 → 2026-02-20

Last 12 months

2

Unique sponsors

8

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

GU

Regulation number

876.4620

Implant

Y

Life-sustain / support

N

GMP exempt

N

Third-party review

Y

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Boston Scientific Corporation	4	0	2025-04-15
Coloplast Corp.	3	0	2022-06-08
Ureteral Stent Company	2	0	2024-03-22
Alton (Shanghai) Medical Instruments Co., Ltd.	1	0	2025-06-18
Shenzhen Trious Medical Technology Co., Ltd.	1	0	2025-05-14
Zhejiang Chuangxiang Medical Technology Co., Ltd.	1	1	2026-02-20
Rocamed Sam	1	0	2022-01-26
Cathegenix (Xiamen) Co., Ltd.	1	1	2025-12-19

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
50693	CPT	—	High	CPT code for placement of ureteral stent including cystourethroscopy
L8695	HCPCS	External recharging system for battery (external) for use with implantable neurostimulator, replacement only ✓ CMS-verified description	Medium	HCPCS code for ureteral stent, implantable

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-02-20	K251890	Zhejiang Chuangxiang Medical Technology Co., Ltd.	Disposable Ureteral Stents
2025-12-19	K251469	Cathegenix (Xiamen) Co., Ltd.	Endura Ureteral Stent and Stent Set
2025-06-18	K243039	Alton (Shanghai) Medical Instruments Co., Ltd.	Ureteral Stents (AF-D series)
2025-05-14	K243830	Shenzhen Trious Medical Technology Co., Ltd.	Disposable ureteral stent
2025-04-15	K250824	Boston Scientific Corporation	Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set
2024-03-22	K232920	Ureteral Stent Company	RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
2022-11-10	K211934	Boston Scientific Corporation	APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
2022-06-08	K213185	Coloplast Corp.	ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits
2022-03-17	K213444	Ureteral Stent Company	RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
2022-02-16	K213186	Coloplast Corp.	NovoFlow Reinforced Ureteral Stent
2022-01-26	K212868	Rocamed Sam	JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
2021-04-26	K200260	Boston Scientific Corporation	Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System
2021-02-25	K201436	Coloplast Corp.	Vortek Single Loop Ureteral Stent
2020-01-02	K191446	Boston Scientific Corporation	Ureteral Stent Systems, Biliary Drainage Catheters