Invuity, Inc.

FDA Regulatory Profile

Invuity, Inc. appears in FDA public data with 2 recalls, 4 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2778-2017, Class II) was initiated on June 12, 2017. Its most recent 510(k) clearance was granted on March 6, 2020.

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