Dornier MAGELLAN Ureteral Access Sheath
FDA 510(k) K201815 · Dornier Medtech America, Inc.
510(k) numberK201815
Submission
- Device name
- Dornier MAGELLAN Ureteral Access Sheath
- Applicant
- Dornier Medtech America, Inc.
Kennesaw, GA, US - Received
- July 1, 2020
- Decision date
- November 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FED – Endoscopic Access Overtube, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
Other 510(k)s with product code FED
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260410 | Single Use Ureteral Access SheathFED · Special | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/11/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | Boston Scientific Corporation | 08/04/2026SE |
| K260965 | CVAC Aspiration SystemFED · Special | Calyxo, Inc. | 04/13/2026SE |
| K260521 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050…FED · Traditional | Zhuhai Pusen Medical Technology Co., Ltd. | 04/06/2026SE |
| K252572 | Prodeon Urethral Sheath SystemFED · Traditional | Prodeon Medical, Inc. | 10/07/2025SE |
| K250128 | Single Use Suction-Evacuation Ureteral Access SheathFED · Traditional | Anhui Happiness Workshop Medical Instruments… | 09/19/2025SE |
| K250132 | Ureteral Access SheathFED · Traditional | Zhejiang YiGao Medical Technology Co., Ltd. | 09/05/2025SE |
| K250695 | Single-use Ureteral Access SheathFED · Traditional | Shenzhen HugeMed Medical Technical Development… | 07/08/2025SE |
| K251599 | Single-use Ureteral Access SheathFED · Special | Hunan Vathin Medical Instrument Co., Ltd. | 07/03/2025SE |
| K250585 | LumenaTM Ureteral Access SheathFED · Traditional | Cathegenix (Xiamen) Co., Ltd. | 06/27/2025SE |
More from Cathegenix (Xiamen) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040…FED · Traditional | 01/31/2025SE |
| K233380 | TRIDENT Mobile Fluoroscopy SystemJAA · Traditional | 06/26/2024SE |
| K221903 | Delta III ProLNS · Traditional | 02/22/2023SE |
| K213252 | Dornier ThulioGEX · Traditional | 07/27/2022SE |
| K220871 | NautilusJAA · Special | 04/18/2022SE |
| K210394 | Electrosurgical accessoryFAS · Traditional | 05/19/2021SE |
| K201074 | Delta III LithotripterLNS · Traditional | 09/03/2020SE |
| K190612 | EQUINOX Balloon Dilatation CatheterEZN · Traditional | 12/06/2019SE |
| K190312 | Dornier Ureteral StentFAD · Traditional | 11/15/2019SE |
| K191187 | Dornier MINNOW Ureteral CatheterEYB · Traditional | 09/18/2019SE |
Questions and answers
When was Dornier MAGELLAN Ureteral Access Sheath cleared by the FDA?
Dornier MAGELLAN Ureteral Access Sheath (K201815) received a 510(k) decision of Substantially Equivalent on November 20, 2020, 142 days after the submission was received.
What is the product code of K201815?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.