510(k) Report

FDA applicant

Theravant Corporation

Cary, NC2 decisions2010–20130 recalls

FDA records 2 decisions for Theravant Corporation (Cary, NC) from 2010 to 2013: 2 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONF (Powered Light Based Non-Laser Surgical…). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2013

2010: 12013: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Theravant Corporation by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument1decision
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K101415TheraclearTheravant Corporation · 20101cites it

What has FDA decided for it lately?

  • K123889Acleara, TheraclearTheravant Corporation · 2013
  • K101415TheraclearTheravant Corporation · 2010

All 2 as Theravant Corporation →