SCAR 3
K-Number: K211362 · 2021-08-25
ApplicantEl.En Electronic Engineering Spa
Decision Date2021-08-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SCAR 3 is a medical device manufactured by El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2021-08-25 under approval number K211362. 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 SCAR 3?
SCAR 3 is a medical device that received FDA 510(k) clearance on 2021-08-25. It is manufactured by El.En Electronic Engineering Spa. The 510(k) number is K211362.
When was SCAR 3 approved by the FDA?
SCAR 3 received FDA 510(k) clearance on 2021-08-25, under approval number K211362.
What company makes SCAR 3?
SCAR 3 is manufactured by El.En Electronic Engineering Spa.
What is the FDA product code for SCAR 3?
The FDA product code for SCAR 3 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.