Invuity, Inc.

Medical device manufacturer in San Francisco, CA.

4510(k) clearances
0PMA approvals
2recalls

Device types

510(k) clearances

510(k)DeviceDecision
K191583PhotonBlade with Smoke EvacuationGEI · Traditional 03/06/2020SE
K162053PhotonBladeGEI · Traditional 09/15/2016SE
K113697Eigr Surgical Illumination SystemFST · Special 02/10/2012SE
K090070Invuity Britefield Mcculloch Retractor SystemFST · Traditional 04/22/2009SE

Recalls

RecallProductInitiated
Z-2778-2017 Class IIINVUITY(R) PhotonBlade(TM), REF PB1A small number of customer observations were recently received which related to possible unintended energy… 06/12/2017Terminated
Z-0007-2013 Class IIBriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included…Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field.… 05/12/2012Terminated