510(k) Report

FDA applicant

Medwaves Incorporated

San Diego, CA4 decisions2007–20200 recalls

FDA records 4 decisions for Medwaves Incorporated (San Diego, CA) from 2007 to 2020: 4 510(k) clearances. All are in product code NEY (System, Ablation, Microwave And Accessories). Its devices cite 10 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medwaves, Inc.”.

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 Medwaves Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 12009: 12015: 12020: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medwaves Incorporated by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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