Invuity, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2778-2017Class IIINVUITY(R) PhotonBlade(TM), REF PB1June 12, 2017
Z-0007-2013Class IIBriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr anMay 12, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K191583PhotonBlade with Smoke EvacuationMarch 6, 2020
K162053PhotonBladeSeptember 15, 2016
K113697EIGR SURGICAL ILLUMINATION SYSTEMFebruary 10, 2012
K090070INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEMApril 22, 2009