FED — Endoscopic Access Overtube, Gastroenterology-Urology Class II
FDA product code FED covers "Endoscopic Access Overtube, Gastroenterology-Urology", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260965 | calyxo | CVAC Aspiration System | April 13, 2026 |
| K260521 | zhuhai pusen medical technology co | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100- | April 6, 2026 |
| 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 |