510(k) Report

FDA applicant

Activ Surgical, Inc.

Boston, MA2 decisions2021–20230 recalls

FDA records 2 decisions for Activ Surgical, Inc. (Boston, MA) from 2021 to 2023: 2 510(k) clearances. All are in product code OWN (Confocal Optical Imaging). Its devices cite 2 predicates, 1 of them its own earlier devices. No 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2023

2021: 12023: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Activ Surgical, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Activ Surgical, 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?

  • OWNConfocal Optical Imaging2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc. · 20212cite it

What has FDA decided for it lately?

  • K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc. · 2023
  • K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc. · 2021

All 2 as Activ Surgical, Inc. →