FED
- Product code
- FED
- Device name
- Endoscopic Access Overtube, Gastroenterology-Urology
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 21
- Summaries archived here
- 18 (direct download)
- 510(k) clearances (all years, FDA)
- 102 (all years; only the last 3 years are listed here)
FDA classification definition
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
510(k) clearances, last 3 years (21)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261915 | 2026-08-04 | Boston Scientific Corporation | Navigator Flex Ureteral Access Sheath Set | |
| K260965 | 2026-04-13 | Calyxo, Inc. | CVAC Aspiration System | |
| K260521 | 2026-04-06 | Zhuhai Pusen Medical Technology Co., L… | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100… | |
| K252572 | 2025-10-07 | Prodeon Medical, Inc. | Prodeon Urethral Sheath System | |
| K250128 | 2025-09-19 | Anhui Happiness Workshop Medical Instr… | Single Use Suction-Evacuation Ureteral Access Sheath | |
| K250132 | 2025-09-05 | Zhejiang YiGao Medical Technology Co.,… | Ureteral Access Sheath | |
| K250695 | 2025-07-08 | Shenzhen HugeMed Medical Technical Dev… | Single-use Ureteral Access Sheath | |
| K251599 | 2025-07-03 | Hunan Vathin Medical Instrument Co., L… | Single-use Ureteral Access Sheath | |
| K250585 | 2025-06-27 | Cathegenix (Xiamen) Co., Ltd. | LumenaTM Ureteral Access Sheath | FDA |
| K250452 | 2025-06-02 | MacroLux Medical Technology Co., Ltd. | CoralWell Single-use Ureteral Access Sheath (NS-083… | — |
| K243710 | 2025-04-11 | Shenzhen Trious Medical Technology Co.… | Disposable ureteral access sheath | |
| K250517 | 2025-03-21 | Boston Scientific Corporation | Navigator HD Ureteral Access Sheath Set 11/13 F x 2… | |
| K243820 | 2025-01-31 | Dornier Medtech America | Hoover Negative Pressure Access Sheath (Hoover) (Hoo… | |
| K243025 | 2025-01-30 | Seplou (Zhuhai) Co., Ltd. | Ureteral Access Sheath | |
| K242173 | 2024-11-12 | Coloplast Corp. | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL… | |
| K243091 | 2024-11-01 | Fujifilm Corporation | Over-tube (TR-1108A) | |
| K240167 | 2024-10-08 | Hunan Vathin Medical Instrument Co., L… | Single-use Ureteral Access Sheath | |
| K241181 | 2024-08-02 | Dongguan Zsr Biomedical Technology Com… | Disposable Ureteral Guide Sheath | FDA |
| K240853 | 2024-06-27 | Neptune Medical, Inc. | Pathfinder® CR System | |
| K233472 | 2024-02-02 | Calyxo, Inc. | CVAC Aspiration System + CVAC Image Processor | |
| K230752 | 2023-09-15 | FUJIFILM Healthcare Americas Corporati… | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tub… |
Official FDA classification page: FED
Classification and pathway per current FDA publications. Data from openFDA (CC0).