510(k) Report

FDA applicant

Dgi Technologies

Howell, NJ2 decisions2019–20230 recalls

FDA records 2 decisions for Dgi Technologies (Howell, NJ) from 2019 to 2023: 2 510(k) clearances. All are in product code GEH (Unit, Cryosurgical, Accessories). Its devices cite 3 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2023

2019: 12023: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Dgi Technologies by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dgi Technologies’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?

  • GEHUnit, Cryosurgical, Accessories2decisions

Whose devices does it build on?

Its devices cite 3 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.

  • K190747ClaritagDgi Technologies · 20192cite it

What has FDA decided for it lately?

  • K222356Claritag AdvancedDgi Technologies · 2023
  • K190747ClaritagDgi Technologies · 2019

All 2 as Dgi Technologies →