LumenR Tissue Retractor System
K-Number: K153698 · 2016-04-19
ApplicantLumenr, LLC
Decision Date2016-04-19
Product CodeODB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
LumenR Tissue Retractor System is a medical device manufactured by Lumenr, LLC. It received FDA 510(k) clearance on 2016-04-19 under approval number K153698. The device is classified under product code ODB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LumenR Tissue Retractor System?
LumenR Tissue Retractor System is a medical device that received FDA 510(k) clearance on 2016-04-19. It is manufactured by Lumenr, LLC. The 510(k) number is K153698.
When was LumenR Tissue Retractor System approved by the FDA?
LumenR Tissue Retractor System received FDA 510(k) clearance on 2016-04-19, under approval number K153698.
What company makes LumenR Tissue Retractor System?
LumenR Tissue Retractor System is manufactured by Lumenr, LLC.
What is the FDA product code for LumenR Tissue Retractor System?
The FDA product code for LumenR Tissue Retractor System is ODB.
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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.