FDA applicant

Brymill Cryogenic Systems

Ellington, CT1 decision2020–20200 recalls

FDA records 1 decision for Brymill Cryogenic Systems (Ellington, CT) in 2020: 1 510(k) clearance. All are in product code GEH (Unit, Cryosurgical, Accessories). Its devices cite 3 predicates, 0 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 Brymill Cryogenic Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Brymill Cryogenic Systems by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Brymill Cryogenic Systems’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 “Brymill”

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

Brymill Corp. 3 Brymill Cryogenic Cystems 1

Brymill Cryogenic Systems

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Brymill”