FDA applicant
Olsen Electrosurgical, Inc.
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
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
Class I Class II/III not classified
Planning a device like Olsen Electrosurgical, 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) ReportOther applicant names beginning “Olsen”
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