FED — Endoscopic Access Overtube, Gastroenterology-Urology Class II
Classification Details
- Product Code
- FED
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252572 | prodeon medical | Prodeon Urethral Sheath System | October 7, 2025 |
| K250128 | anhui happiness workshop medical instruments co | Single Use Suction-Evacuation Ureteral Access Sheath | September 19, 2025 |
| K250132 | zhejiang yigao medical technology co | Ureteral Access Sheath | September 5, 2025 |
| K250695 | shenzhen hugemed medical technical development co | Single-use Ureteral Access Sheath | July 8, 2025 |
| K251599 | hunan vathin medical instrument co | Single-use Ureteral Access Sheath | July 3, 2025 |
| K250585 | cathegenix (xiamen) co | LumenaTM Ureteral Access Sheath | June 27, 2025 |
| K250452 | macrolux medical technology co | CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0 | June 2, 2025 |
| K243710 | shenzhen trious medical technology co | Disposable ureteral access sheath | April 11, 2025 |
| K250517 | boston scientific corporation | Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator | March 21, 2025 |
| K243820 | dornier medtech america | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, I | January 31, 2025 |
| K243025 | seplou (zhuhai) co | Ureteral Access Sheath | January 30, 2025 |
| K242173 | coloplast | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, | November 12, 2024 |
| K243091 | fujifilm corporation | Over-tube (TR-1108A) | November 1, 2024 |
| K240167 | hunan vathin medical instrument co | Single-use Ureteral Access Sheath | October 8, 2024 |
| K241181 | dongguan zsr biomedical technology company limited | Disposable Ureteral Guide Sheath | August 2, 2024 |
| K240853 | neptune medical | Pathfinder® CR System | June 27, 2024 |
| K233472 | calyxo | CVAC Aspiration System + CVAC Image Processor | February 2, 2024 |
| K230752 | fujifilm healthcare americas corporation | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | September 15, 2023 |
| K230748 | youcare technology co.,ltd. (wuhan) | Disposable Ureteral Access Sheath | August 2, 2023 |
| K230801 | neptune medical | Pathfinder Endoscope Overtube with Balloon Device | July 28, 2023 |