Endo-Ease Endoscopic Overtube
FDA 510(k) K052084 · Spirus Medical, Inc.
510(k) numberK052084
Submission
- Device name
- Endo-Ease Endoscopic Overtube
- Applicant
- Spirus Medical, Inc.
Ayer, MA, US - Received
- August 2, 2005
- Decision date
- September 14, 2005
- 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 |
|---|---|---|
| K080050 | Spirus Medical Endo-Ease Endoscopic OvertubeFED · Traditional | 05/06/2008SE |
| K080042 | Spirus Medical Surgical InstrumentKMJ · Traditional | 04/03/2008SE |
| K062805 | Modification to Endo-EaseFED · Special | 10/13/2006SE |
| K060235 | Endo-Ease Endoscopic OvertubeFDA · Traditional | 08/04/2006SE |
Questions and answers
When was Endo-Ease Endoscopic Overtube cleared by the FDA?
Endo-Ease Endoscopic Overtube (K052084) received a 510(k) decision of Substantially Equivalent on September 14, 2005, 43 days after the submission was received.
What is the product code of K052084?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.