Company ยท US
Invuity, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2020. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 6, 2020 | K191583 | PhotonBlade with Smoke Evacuation Invuity, Inc. | GEI |
| Sep 15, 2016 | K162053 | PhotonBlade Invuity, Inc. | GEI |
| Feb 10, 2012 | K113697 | EIGR SURGICAL ILLUMINATION SYSTEM Invuity, Inc. | FST |
| Apr 22, 2009 | K090070 | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM Invuity, Inc. | FST |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2017 | Invuity, Inc. INVUITY(R) PhotonBlade(TM), REF PB1 Terminated |
GEI | K162053 |
| Oct 3, 2012 | Invuity, Inc. BriteField illuminated Suction Device;
Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray.
The Invuity Brite Field Illuminated Suction Device is intended to a Terminated |
JOL | None listed |