510(k) K252572

Device: Prodeon Urethral Sheath System
Applicant: Prodeon Medical, Inc.
510(k) number: K252572
Product code: FED
Decision: Substantially Equivalent (SESE)
Decision date: 2025-10-07
Date received: 2025-08-14
Regulation: 876.1500
Classification name: Endoscopic Access Overtube, Gastroenterology-Urology
Medical specialty: Gastroenterology, Urology
Review panel: Gastroenterology, Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Elaine Aplaon
Address: 452 Oakmead Pkwy. Sunnyvale CA US 94085 94085

FDA Registration Numbers

2024311
3032859397
2029275
3035710892
1526611
1651395
3010400865
8043746
2431166
3016881508
3042225166
1000121056
8010047
3008791915
3011050570
3013687468
2936485
3016690337
3015895045
1018233
3006161756
2245304
3030511423
9611102
3004361445
9610711
3000308637
1220477
3004837686
3014683069
3005580113
3010273872
3034608931
3040391040
9610773
3029929134
3038296436
2124215
1422634
9611590
3008386005
3010419931
1825146
9611174
3033848208
3042172882
3002808148
3004180226
3036978610
1820334
3014644276
3013944123
3009763019
2242464
3014769442
1037955
1828132
3030733800
9611668
3007007790
1320894
1223490
3033589330
3005099803
3005382983
3015219237
9614641
3021023752
1836324
1000393132
3003168101
3005941719
1647149
3015225571
3013460719
3010188783
3008837339
1528319
3006082230

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FED

510(k)	Device	Applicant	Decision date
K260965	CVAC Aspiration System	Calyxo, Inc.	2026-04-13
K260521	ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)	Zhuhai Pusen Medical Technology Co., Ltd.	2026-04-06
K250128	Single Use Suction-Evacuation Ureteral Access Sheath	Anhui Happiness Workshop Medical Instruments Co., Ltd.	2025-09-19
K250132	Ureteral Access Sheath	Zhejiang YiGao Medical Technology Co., Ltd.	2025-09-05
K250695	Single-use Ureteral Access Sheath	Shenzhen HugeMed Medical Technical Development Co., Ltd.	2025-07-08
K251599	Single-use Ureteral Access Sheath	Hunan Vathin Medical Instrument Co., Ltd.	2025-07-03
K250585	LumenaTM Ureteral Access Sheath	Cathegenix (Xiamen) Co., Ltd.	2025-06-27
K250452	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)	MacroLux Medical Technology Co., Ltd.	2025-06-02
K243710	Disposable ureteral access sheath	Shenzhen Trious Medical Technology Co., Ltd.	2025-04-11
K250517	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	Boston Scientific Corporation	2025-03-21
K243820	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	Dornier Medtech America	2025-01-31
K243025	Ureteral Access Sheath	Seplou (Zhuhai) Co., Ltd.	2025-01-30
K242173	Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)	Coloplast Corp.	2024-11-12
K243091	Over-tube (TR-1108A)	Fujifilm Corporation	2024-11-01
K240167	Single-use Ureteral Access Sheath	Hunan Vathin Medical Instrument Co., Ltd.	2024-10-08