510(k) K250517
- Device
- 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
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K250517
- Product code
- FED
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-21
- Date received
- 2025-02-21
- Regulation
- 876.1500
- Classification name
- Endoscopic Access Overtube, Gastroenterology-Urology
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Timilehin Adenekan
- Address
- 100 Boston Scientific Way Urology Division Marlborough MA US 01752 01752
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
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 |
| K252572 | Prodeon Urethral Sheath System | Prodeon Medical, Inc. | 2025-10-07 |
| 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 |
| 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 |