ClearPetra Suction-Evacuation Sheath
FDA 510(k) K203119 · Well Lead Medical Co., Ltd.
510(k) numberK203119
Submission
- Device name
- ClearPetra Suction-Evacuation Sheath
- Applicant
- Well Lead Medical Co., Ltd.
Guangzhou, CN - Received
- October 16, 2020
- Decision date
- December 9, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…GBM · Traditional | 03/05/2025SE |
| K220722 | PVC Hydrophilic Urethral CatheterEZD · Traditional | 05/22/2023SE |
| K220036 | Wellead Ureteral CatheterKOD · Traditional | 12/16/2022SE |
| K211543 | Wei Nasal Jet TubeBTR · Traditional | 07/21/2022SE |
| K211814 | Wellead Endoscopic SealODC · Traditional | 01/14/2022SE |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature SensorEZL · Special | 04/08/2021SE |
| K182739 | Endotracheal Tube with Evacuation LumenBTR · Special | 12/11/2019SE |
| K162340 | Stomach TubeKNT · Traditional | 10/11/2017SE |
| K160801 | Well Lead Extraction BagGCJ · Traditional | 11/29/2016SE |
| K161110 | ClearPetra Suction-Evacuation SheathFED · Traditional | 10/12/2016SE |
Questions and answers
When was ClearPetra Suction-Evacuation Sheath cleared by the FDA?
ClearPetra Suction-Evacuation Sheath (K203119) received a 510(k) decision of Substantially Equivalent on December 9, 2020, 54 days after the submission was received.
What is the product code of K203119?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.