Wellead Endoscopic Seal
FDA 510(k) K211814 · Well Lead Medical Co., Ltd.
510(k) numberK211814
Submission
- Device name
- Wellead Endoscopic Seal
- Applicant
- Well Lead Medical Co., Ltd.
Guangzhou, CN - Received
- June 11, 2021
- Decision date
- January 14, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODC – Endoscope Channel Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To give the endoscope channel additional or improved functionality.
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| K202134 | Well Lead All Silicone Foley Catheter with Temperature SensorEZL · Special | 04/08/2021SE |
| K203119 | ClearPetra Suction-Evacuation SheathFED · Special | 12/09/2020SE |
| 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 Wellead Endoscopic Seal cleared by the FDA?
Wellead Endoscopic Seal (K211814) received a 510(k) decision of Substantially Equivalent on January 14, 2022, 217 days after the submission was received.
What is the product code of K211814?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.