mi-eye 3 needlescope with cannula, mi-tablet 3
K-Number: K212556 · 2021-09-15
ApplicantTrice Medical, Inc.
Decision Date2021-09-15
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
mi-eye 3 needlescope with cannula, mi-tablet 3 is a medical device manufactured by Trice Medical, Inc.. It received FDA 510(k) clearance on 2021-09-15 under approval number K212556. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the mi-eye 3 needlescope with cannula, mi-tablet 3?
mi-eye 3 needlescope with cannula, mi-tablet 3 is a medical device that received FDA 510(k) clearance on 2021-09-15. It is manufactured by Trice Medical, Inc.. The 510(k) number is K212556.
When was mi-eye 3 needlescope with cannula, mi-tablet 3 approved by the FDA?
mi-eye 3 needlescope with cannula, mi-tablet 3 received FDA 510(k) clearance on 2021-09-15, under approval number K212556.
What company makes mi-eye 3 needlescope with cannula, mi-tablet 3?
mi-eye 3 needlescope with cannula, mi-tablet 3 is manufactured by Trice Medical, Inc..
What is the FDA product code for mi-eye 3 needlescope with cannula, mi-tablet 3?
The FDA product code for mi-eye 3 needlescope with cannula, mi-tablet 3 is HRX.
Other Devices by Trice Medical, Inc.
Related Devices (Code: HRX)
K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation
K161878PORTAGE SystemBaylis Medical Company, Inc.
K162475mi-eye 2, mi-eye 2 monitorTrice Medical
K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaProsurg, Inc.
K160249ULTRA TelescopesOlympus Winter & Ibe GmbH
K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingStryker Corporation
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.