FDA applicant

Channel Medsystems, Inc.

Emeryville1 decision2019–20191 recall

FDA records 1 decision for Channel Medsystems, Inc. (Emeryville) in 2019: 1 original PMA approval. All are in product code MNB (Device, Thermal Ablation, Endometrial). 1 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2025

2019high 1 (2025) · low 0 (2019)2026

Class I Class II/III not classified

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

Planning a device like Channel Medsystems, 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

Other applicant names beginning “Channel”

FDA records each applicant name separately; these may or may not be the same firm.

Channel-Markers Medical, LLC 2

Channel Medsystems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Channel”