Invuity, Inc.
Sunnyvale, CA, US
Invuity, Inc. appears in FDA device records in Sunnyvale, CA. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Invuity, Inc. between 2009 and 2020. The busiest year on record is 2009, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2012 | 1 |
| 2016 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K191583 | PhotonBlade with Smoke Evacuation | GEI | Substantially Equivalent | |
| K162053 | PhotonBlade | GEI | Substantially Equivalent | |
| K113697 | EIGR SURGICAL ILLUMINATION SYSTEM | FST | Substantially Equivalent | |
| K090070 | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM | FST | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2778-2017 | INVUITY(R) PhotonBlade(TM), REF PB1 | A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients. | Class II | Terminated | |
| Z-0007-2013 | 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 aspirate from the surgical site and to provide illumination from a high intensity light source. | Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced at that time. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Invuity, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain