Product code FED
- Device name
- Endoscopic Access Overtube, Gastroenterology-Urology
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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, N... | 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 A... | 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 |
| K241181 | Disposable Ureteral Guide Sheath | Dongguan Zsr Biomedical Technology Company Limited | 2024-08-02 |
| K240853 | Pathfinder® CR System | Neptune Medical, Inc. | 2024-06-27 |
| K233472 | CVAC Aspiration System + CVAC Image Processor | Calyxo, Inc. | 2024-02-02 |
| K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | FUJIFILM Healthcare Americas Corporation | 2023-09-15 |
| K230748 | Disposable Ureteral Access Sheath | Youcare Technology Co.,Ltd. (Wuhan) | 2023-08-02 |
| K230801 | Pathfinder Endoscope Overtube with Balloon Device | Neptune Medical, Inc. | 2023-07-28 |
| K220065 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-05-25 |
| K200770 | Mini PCNL-System | Trokamed GmbH | 2021-07-30 |
| K211301 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2021-05-28 |
| K203165 | Disposable Ureteral Access Sheath | Suzhou Beyo Medical Technology Co., Ltd. | 2021-04-30 |
| K203119 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2020-12-09 |
| K201815 | Dornier MAGELLAN Ureteral Access Sheath | Dornier Medtech America, Inc. | 2020-11-20 |
| K200419 | Kalera Vacuum Aspiration Catheter (K-VAC) | Kalera Medical, Inc. | 2020-05-22 |
| K192691 | PatCom Single-Use Introducer | H&A Mui Enterprises, Inc. | 2020-02-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06936345101543 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | 2026-05-27 |
| 06936345104469 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | 2026-05-27 |
| 06936345104476 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | 2026-05-27 |
| 06936345104483 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | 2026-05-27 |
| 06936345104490 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | 2026-05-27 |
| 06936345104544 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | 2026-05-27 |
| 06936345104551 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | 2026-05-27 |
| 06936345104568 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | 2026-05-27 |
| 06936345104575 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | 2026-05-27 |
| 06936345101536 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | 2026-05-27 |
| 10860006600805 | Ancora | Aspero Medical, Inc. | 2023-10-26 |
| 10678467506877 | Mui Scientific | H & A Mui Enterprises Inc | 2023-07-04 |
| 10678467507492 | Mui Scientific | H & A Mui Enterprises Inc | 2022-08-19 |
| 10678467507065 | Mui Scientific | H & A Mui Enterprises Inc | 2020-12-17 |
| 08714729974628 | ORISE™ | BOSTON SCIENTIFIC CORPORATION | 2018-03-05 |
| 08714729974611 | ORISE™ | BOSTON SCIENTIFIC CORPORATION | 2018-03-05 |
| 08714729974604 | ORISE™ | BOSTON SCIENTIFIC CORPORATION | 2018-03-05 |
| 08714729751533 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729429920 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751540 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729429944 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751526 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751519 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751502 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729470359 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729470342 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729430018 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729429999 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729429968 | Navigator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 10680651928105 | Halyard | Avanos Medical, Inc. | 2016-09-15 |