FDA applicant

Birtcher Electro Medical Systems

Englewood, CO1 decision1990–19900 recalls

FDA records 1 decision for Birtcher Electro Medical Systems (Englewood, CO) in 1990: 1 510(k) clearance. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). 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 Birtcher Electro Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Birtcher Electro Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Birtcher Electro Medical Systems’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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Other applicant names beginning “Birtcher”

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

Birtcher Corp. 27 Birtcher Medical Systems, Inc. 13

Birtcher Electro Medical Systems

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Birtcher”