SurgeoBite
K-Number: K172978 · 2017-12-22
ApplicantSurgovations, LLC
Decision Date2017-12-22
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
SurgeoBite is a medical device manufactured by Surgovations, LLC. It received FDA 510(k) clearance on 2017-12-22 under approval number K172978. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SurgeoBite?
SurgeoBite is a medical device that received FDA 510(k) clearance on 2017-12-22. It is manufactured by Surgovations, LLC. The 510(k) number is K172978.
When was SurgeoBite approved by the FDA?
SurgeoBite received FDA 510(k) clearance on 2017-12-22, under approval number K172978.
What company makes SurgeoBite?
SurgeoBite is manufactured by Surgovations, LLC.
What is the FDA product code for SurgeoBite?
The FDA product code for SurgeoBite is JXL.
Related Devices (Code: JXL)
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.