Dual Switch
K-Number: K211605 · 2022-09-22
ApplicantLaser Engineering, Inc.
Decision Date2022-09-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Dual Switch is a medical device manufactured by Laser Engineering, Inc.. It received FDA 510(k) clearance on 2022-09-22 under approval number K211605. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dual Switch?
Dual Switch is a medical device that received FDA 510(k) clearance on 2022-09-22. It is manufactured by Laser Engineering, Inc.. The 510(k) number is K211605.
When was Dual Switch approved by the FDA?
Dual Switch received FDA 510(k) clearance on 2022-09-22, under approval number K211605.
What company makes Dual Switch?
Dual Switch is manufactured by Laser Engineering, Inc..
What is the FDA product code for Dual Switch?
The FDA product code for Dual Switch is GEX. This falls under the Gastroenterology category.
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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.