FDA applicant

Birtcher Medical Systems, Inc.

Irvine, CA13 decisions1991–19954 recalls

FDA records 13 decisions for Birtcher Medical Systems, Inc. (Irvine, CA) from 1991 to 1995: 13 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GEI (Electrosurgical, Cutting & Coagulation &…). 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Birtcher Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Birtcher Medical Systems, Inc. since 2007.

Recalls per year

4in 2008

2007high 4 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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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 Electro Medical Systems 1

Birtcher Medical Systems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Birtcher”