Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of StrykerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Invuity with 4 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Mar 6, 2020: PhotonBlade with Smoke Evacuation.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 6, 2020 | PhotonBlade with Smoke EvacuationK191583 · GEI | 510(k) clearances |
| Jun 12, 2017 | INVUITY(R) PhotonBlade(TM), REF PB1Class II · A small number of customer observations were recently received which related to possible unintended energy discharge wit | Device recalls |
| Sep 15, 2016 | PhotonBladeK162053 · GEI | 510(k) clearances |
| May 12, 2012 | BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Class II · Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not | Device recalls |
| Feb 10, 2012 | EIGR SURGICAL ILLUMINATION SYSTEMK113697 · FST | 510(k) clearances |
| Apr 22, 2009 | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEMK090070 · FST | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
