510(k) Report

FDA applicant

Olsen Electrosurgical, Inc.

Concord, CA11 decisions1988–19944 recalls

FDA records 11 decisions for Olsen Electrosurgical, Inc. (Concord, CA) from 1988 to 1994: 11 510(k) clearances. Most are in product codes HAM (Apparatus, Electrosurgical) 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Olsen Electrosurgical, Inc. since 2007.

Recalls per year

4in 2012

2012: 4
2007high 4 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Olsen Electrosurgical, 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 “Olsen”

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