Disposable electrosurgical pencil (MD1000)
K-Number: K232460 · 2023-10-11
Decision Date2023-10-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable electrosurgical pencil (MD1000) is a medical device manufactured by Shenzhen Mecun Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2023-10-11 under approval number K232460. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Disposable electrosurgical pencil (MD1000)?
Disposable electrosurgical pencil (MD1000) is a medical device that received FDA 510(k) clearance on 2023-10-11. It is manufactured by Shenzhen Mecun Medical Supply Co., Ltd.. The 510(k) number is K232460.
When was Disposable electrosurgical pencil (MD1000) approved by the FDA?
Disposable electrosurgical pencil (MD1000) received FDA 510(k) clearance on 2023-10-11, under approval number K232460.
What company makes Disposable electrosurgical pencil (MD1000)?
Disposable electrosurgical pencil (MD1000) is manufactured by Shenzhen Mecun Medical Supply Co., Ltd..
What is the FDA product code for Disposable electrosurgical pencil (MD1000)?
The FDA product code for Disposable electrosurgical pencil (MD1000) is GEI.
Other Devices by Shenzhen Mecun Medical Supply Co., Ltd.
Related Devices (Code: GEI)
K161307NICO MyriadNico Corporation
K163190InMode RF SystemInmode MD , Ltd.
K163373PK AIMGyrus Acmi, Inc.
K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL
K162676Voyant Open Fusion DeviceApplied Medical Resources
K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien
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.