FED · Endoscopic Access Overtube, Gastroenterology-Urology

Device class

Class II

Regulation 876.1500

Total clearances

2020-02-21 → 2026-04-13

Last 12 months

Unique sponsors

Definition

What is Endoscopic Access Overtube, Gastroenterology-Urology

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

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
Neptune Medical, Inc.	3	0	2024-06-27
Dornier Medtech America, Inc.	2	0	2025-01-31
Calyxo, Inc.	2	1	2026-04-13
Hunan Vathin Medical Instrument Co., Ltd.	2	0	2025-07-03
Prodeon Medical, Inc.	1	1	2025-10-07
Dongguan Zsr Biomedical Technology Company Limited	1	0	2024-08-02
Shenzhen Trious Medical Technology Co., Ltd.	1	0	2025-04-11
MacroLux Medical Technology Co., Ltd.	1	0	2025-06-02
Cathegenix (Xiamen) Co., Ltd.	1	0	2025-06-27
Youcare Technology Co.,Ltd. (Wuhan)	1	0	2023-08-02
Fujifilm Corporation	1	0	2024-11-01
FUJIFILM Healthcare Americas Corporation	1	0	2023-09-15
Well Lead Medical Co., Ltd.	1	0	2020-12-09
Zhejiang YiGao Medical Technology Co., Ltd.	1	1	2025-09-05
Coloplast Corp.	1	0	2024-11-12
Zhejiang Chuangxiang Medical Technology Co., Ltd.	1	0	2022-05-25
Seplou (Zhuhai) Co., Ltd.	1	0	2025-01-30
Kalera Medical, Inc.	1	0	2020-05-22
H&A Mui Enterprises, Inc.	1	0	2020-02-21
Zhuhai Pusen Medical Technology Co., Ltd.	1	1	2026-04-06
Trokamed GmbH	1	0	2021-07-30
Shenzhen HugeMed Medical Technical Development Co., Ltd.	1	0	2025-07-08
Boston Scientific Corporation	1	0	2025-03-21
Anhui Happiness Workshop Medical Instruments Co., Ltd.	1	1	2025-09-19
Suzhou Beyo Medical Technology Co., Ltd.	1	0	2021-04-30

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.

Code	Type	Description	Confidence	Rationale
43235	CPT	—	Medium	EGD procedure where overtube facilitates access
C1755	HCPCS	Catheter, intraspinal ✓ CMS-verified description	Medium	Endoscopic overtube as device component or supply

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-13	K260965	Calyxo, Inc.	CVAC Aspiration System
2026-04-06	K260521	Zhuhai Pusen Medical Technology Co., Ltd.	ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
2025-10-07	K252572	Prodeon Medical, Inc.	Prodeon Urethral Sheath System
2025-09-19	K250128	Anhui Happiness Workshop Medical Instruments Co., Ltd.	Single Use Suction-Evacuation Ureteral Access Sheath
2025-09-05	K250132	Zhejiang YiGao Medical Technology Co., Ltd.	Ureteral Access Sheath
2025-07-08	K250695	Shenzhen HugeMed Medical Technical Development Co., Ltd.	Single-use Ureteral Access Sheath
2025-07-03	K251599	Hunan Vathin Medical Instrument Co., Ltd.	Single-use Ureteral Access Sheath
2025-06-27	K250585	Cathegenix (Xiamen) Co., Ltd.	LumenaTM Ureteral Access Sheath
2025-06-02	K250452	MacroLux Medical Technology Co., Ltd.	CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)
2025-04-11	K243710	Shenzhen Trious Medical Technology Co., Ltd.	Disposable ureteral access sheath
2025-03-21	K250517	Boston Scientific Corporation	Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006
2025-01-31	K243820	Dornier Medtech America	Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250
2025-01-30	K243025	Seplou (Zhuhai) Co., Ltd.	Ureteral Access Sheath
2024-11-12	K242173	Coloplast Corp.	Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
2024-11-01	K243091	Fujifilm Corporation	Over-tube (TR-1108A)
2024-10-08	K240167	Hunan Vathin Medical Instrument Co., Ltd.	Single-use Ureteral Access Sheath
2024-08-02	K241181	Dongguan Zsr Biomedical Technology Company Limited	Disposable Ureteral Guide Sheath
2024-06-27	K240853	Neptune Medical, Inc.	Pathfinder® CR System
2024-02-02	K233472	Calyxo, Inc.	CVAC Aspiration System + CVAC Image Processor
2023-09-15	K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
2023-08-02	K230748	Youcare Technology Co.,Ltd. (Wuhan)	Disposable Ureteral Access Sheath
2023-07-28	K230801	Neptune Medical, Inc.	Pathfinder Endoscope Overtube with Balloon Device
2022-05-25	K220065	Zhejiang Chuangxiang Medical Technology Co., Ltd.	Single Use Ureteral Access Sheath
2021-07-30	K200770	Trokamed GmbH	Mini PCNL-System
2021-05-28	K211301	Neptune Medical, Inc.	Pathfinder Endoscope Overtube