510(k) K172289
- Device
- PAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
- Applicant
- Q Urological Corporation
- 510(k) number
- K172289
- Product code
- FAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-10-04
- Date received
- 2017-07-31
- Regulation
- 876.4620
- Classification name
- Stent, Ureteral
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Scott Epstein
- Address
- 15 Kearney Rd. Needham MA US 02492 02492
FDA Registration Numbers
- 3010155661
- 2125050
- 3012050423
- 1037955
- 2183744
- 3016678045
- 3007695959
- 1828132
- 2527072
- 3017210488
- 1313046
- 9610711
- 3008797804
- 3015309643
- 3005580113
- 3006950086
- 9681442
- 3011642792
- 2246552
- 9617744
- 3010273872
- 3001845648
- 3003790304
- 3033589330
- 1048735
- 2124215
- 1123137
- 9611590
- 3005099803
- 3002807314
- 3016096097
- 1424778
- 3005987240
- 1721504
- 1000121056
- 1825146
- 3021632375
- 3011050570
- 3024807849
- 1000393132
- 2027111
- 3033848208
- 2030624
- 3005941719
- 3003814961
- 1646831
- 3015225571
- 3010131137
- 3009051888
- 3005232773
- 3014246639
- 3013460719
- 1820334
- 1647149
- 3007156625
- 2126666
- 1018233
- 3009763019
- 1225687
- 3012536737
- 3012649202
- 9681477
- 9681260
- 3004859241
- 3006082230
- 3009526575
- 3030087693
- 3003915875
- 3004365956
- 3013023255
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00811503033477 | Q UROLOGICAL FUSELAGE AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2020-07-16 |
| 00811503033484 | Q UROLOGICAL FUSELAGE AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2020-07-16 |
| 10811503033474 | Q UROLOGICAL FUSELAGE AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2020-07-16 |
| 10811503033481 | Q UROLOGICAL FUSELAGE AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2020-07-16 |
| 00811503033316 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503033323 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503033309 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503033279 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503033262 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503033255 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503033248 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503031756 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503031749 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503031695 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503031688 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503031671 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503031664 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503031459 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503031442 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503031435 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503031428 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503030537 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503030520 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503030513 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 00811503030506 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 10811503033269 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 10811503033429 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 10811503033412 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 10811503033405 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
| 10811503033399 | Q UROLOGICAL PERSISTENT AGUAMEDICINA | Q UROLOGICAL CORPORATION | 2019-03-27 |
Other 510(k) Records For Product Code FAD
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251890 | Disposable Ureteral Stents | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-02-20 |
| K251469 | Endura Ureteral Stent and Stent Set | Cathegenix (Xiamen) Co., Ltd. | 2025-12-19 |
| K243039 | Ureteral Stents (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-06-18 |
| K243830 | Disposable ureteral stent | Shenzhen Trious Medical Technology Co., Ltd. | 2025-05-14 |
| K250824 | 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 | Boston Scientific Corporation | 2025-04-15 |
| K232920 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | Ureteral Stent Company | 2024-03-22 |
| K211934 | 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 | Boston Scientific Corporation | 2022-11-10 |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits | Coloplast Corp. | 2022-06-08 |
| K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | Ureteral Stent Company | 2022-03-17 |
| K213186 | NovoFlow Reinforced Ureteral Stent | Coloplast Corp. | 2022-02-16 |
| K212868 | JFil Ureteral Stents, JFil Ureteral Stents ECO KIT | Rocamed Sam | 2022-01-26 |
| K200260 | Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System | Boston Scientific Corporation | 2021-04-26 |
| K201436 | Vortek Single Loop Ureteral Stent | Coloplast Corp. | 2021-02-25 |
| K191446 | Ureteral Stent Systems, Biliary Drainage Catheters | Boston Scientific Corporation | 2020-01-02 |
| K190659 | Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip | Allwin Medical Devices, Inc. | 2019-12-02 |
Legacy Summary
summary
FDA Review
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