HYPNOSPAD
K-Number: K152660 · 2016-11-09
ApplicantSomnics, Inc.
Decision Date2016-11-09
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
HYPNOSPAD is a medical device manufactured by Somnics, Inc.. It received FDA 510(k) clearance on 2016-11-09 under approval number K152660. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HYPNOSPAD?
HYPNOSPAD is a medical device that received FDA 510(k) clearance on 2016-11-09. It is manufactured by Somnics, Inc.. The 510(k) number is K152660.
When was HYPNOSPAD approved by the FDA?
HYPNOSPAD received FDA 510(k) clearance on 2016-11-09, under approval number K152660.
What company makes HYPNOSPAD?
HYPNOSPAD is manufactured by Somnics, Inc..
What is the FDA product code for HYPNOSPAD?
The FDA product code for HYPNOSPAD is LRK.
Other Devices by Somnics, Inc.
Related Devices (Code: LRK)
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.