Wellead Endoscopic Seal
K-Number: K211814 · 2022-01-14
ApplicantWell Lead Medical Co., Ltd.
Decision Date2022-01-14
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Wellead Endoscopic Seal is a medical device manufactured by Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-01-14 under approval number K211814. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Wellead Endoscopic Seal?
Wellead Endoscopic Seal is a medical device that received FDA 510(k) clearance on 2022-01-14. It is manufactured by Well Lead Medical Co., Ltd.. The 510(k) number is K211814.
When was Wellead Endoscopic Seal approved by the FDA?
Wellead Endoscopic Seal received FDA 510(k) clearance on 2022-01-14, under approval number K211814.
What company makes Wellead Endoscopic Seal?
Wellead Endoscopic Seal is manufactured by Well Lead Medical Co., Ltd..
What is the FDA product code for Wellead Endoscopic Seal?
The FDA product code for Wellead Endoscopic Seal is ODC.
Other Devices by Well Lead Medical Co., Ltd.
Related Devices (Code: ODC)
K160403SmartStart Air/Water and Suction ValvesEndochoice, Inc.
K162142Accessory Irrigation AdapterWilson-Cook Medical, Inc.
K181712San Antonio StopcockCook Incorporated
K173105Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst AdapterCook Incorporated
K192258Disposable Valve SetsZhejiang Chuangxiang Medical Technology Co., Ltd.
K192059Bio Guard Air/Water & Suction ValvesUnited States Endoscopy Group, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.