Trans-anal Introducer
FDA 510(k) K171208 · Visionsense, Ltd.
510(k) numberK171208
Submission
- Device name
- Trans-anal Introducer
- Applicant
- Visionsense, Ltd.
Petach Tikva, Hamerkaz, IL - Received
- April 25, 2017
- Decision date
- February 5, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K223020 | VS3-Iridium System (VS3-IR)OWN · Special | 10/28/2022SE |
| K210265 | VS3 Iridium SytemOWN · Traditional | 11/22/2021SE |
| K153548 | VS3 Stereoscopic High Definition Vision SystemHRX · Traditional | 02/22/2016SE |
| K152204 | VS3-IR systemOWN · Traditional | 10/28/2015SE |
| K150018 | VS3-IR-MMS SystemOWN · Traditional | 06/17/2015SE |
| K141002 | VS3 Stereoscopic High Definition Vision SystemHRX · Traditional | 06/26/2014SE |
| K131434 | VS3 Stereoscopic High Definition Vision SystemGWG · Special | 07/16/2013SE |
| K123467 | VS3GCJ · Special | 04/17/2013SE |
| K082355 | Visionsense Stereoscopic Vision SystemHRX · Traditional | 12/15/2008SE |
| K082667 | Visionsense Stereoscopic Vision System (VS System)EOB · Traditional | 10/30/2008SE |
Questions and answers
When was Trans-anal Introducer cleared by the FDA?
Trans-anal Introducer (K171208) received a 510(k) decision of Substantially Equivalent on February 5, 2018, 286 days after the submission was received.
What is the product code of K171208?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.