FDA applicant

AVAVA, Inc.

Waltham, MA6 decisions2021–20250 recalls

FDA records 6 decisions for AVAVA, Inc. (Waltham, MA) from 2021 to 2025: 6 510(k) clearances. Most are in product codes ONG (Powered Laser Surgical Instrument With…) and GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 153 days from receipt to decision, against 125 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 4 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 AVAVA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2021high 2 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

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

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AVAVA, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?