510(k) K983415
- Device
- DELIVERY SHEATH
- Applicant
- CONWAY STUART MEDICAL, INC.
- 510(k) number
- K983415
- Product code
- FED
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-12-01
- Date received
- 1998-09-29
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS WEHMAN
- Address
- 735 Palomar St. Sunnyvale CA US 94086 94086
FDA Registration Numbers#
- 3030733800
- 2936485
- 3030446844
- 2242464
- 3006082230
- 3009763019
- 3006161756
- 3016690337
- 3029929134
- 1828132
- 3016881508
- 3012536737
- 1721504
- 3009051888
- 3032959393
- 3007156625
- 3045323889
- 3005099803
- 3013944123
- 1018233
- 3013557562
- 3044858680
- 2027111
- 8043903
- 3003168101
- 3010273872
- 1037955
- 3013440400
- 3015225571
- 2124215
- 3015136743
- 3004180226
- 8010047
- 3009420598
- 9611174
- 3012345110
- 3005941719
- 3021023752
- 1528319
- 9610773
- 3010400865
- 3029545567
- 3008791915
- 3011050570
- 3004447686
- 1836324
- 3030511423
- 1422634
- 3011270181
- 3010421104
- 1320894
- 3015309643
- 3014683069
- 3000308637
- 2245304
- 9611102
- 3010188783
- 3013247477
- 9614641
- 1000393132
- 3030447506
- 3005987240
- 3035710892
- 3002808148
- 3004361445
- 3033589330
- 3012797688
- 3038296436
- 3042225166
- 3016045249
- 3015895045
- 3015451828
- 3014279513
- 1724474
- 3034608931
- 1223490
- 3014769442
- 3005580113
- 3010141954
- 3040391040
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FED #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260512 | Disposable Ureteral Access Sheath | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2026-09-21 |
| K262262 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2026-09-18 |
| K260410 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-09-11 |
| K261915 | Navigator™ Flex Ureteral Access Sheath Set | Boston Scientific Corporation | 2026-08-04 |
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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