510(k) Report

FDA applicant

Invuity, Inc.

San Francisco, CA4 decisions2009–20201 recall

FDA records 4 decisions for Invuity, Inc. (San Francisco, CA) from 2009 to 2020: 4 510(k) clearances. Most are in product codes FST (Light, Surgical, Fiberoptic) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 7 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Invuity, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2009: 12012: 12016: 12020: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2009high 1 (2017) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Invuity, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Invuity, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FSTLight, Surgical, Fiberoptic2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K162053PhotonBladeInvuity, Inc. · 20161cites it
  • K113697Eigr Surgical Illumination SystemInvuity, Inc. · 20121cites it

What has FDA decided for it lately?

  • K191583PhotonBlade with Smoke EvacuationInvuity, Inc. · 2020
  • K162053PhotonBladeInvuity, Inc. · 20161 recall
  • K113697Eigr Surgical Illumination SystemInvuity, Inc. · 2012
  • K090070Invuity Britefield Mcculloch Retractor SystemInvuity, Inc. · 2009

All 4 as Invuity, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K162053INVUITY (R) PhotonBlade (TM), REF PB1Jun 12, 2017Class II