FDA applicant
Birtcher Corp.
FDA records 27 decisions for Birtcher Corp. (Mchenry, IL) from 1976 to 1988: 27 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and DPS (Electrocardiograph). 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 Birtcher Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Birtcher Corp. since 2007.
Recalls per year
2in 2013
Class I Class II/III not classified
Planning a device like Birtcher Corp.’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 “Birtcher”
FDA records each applicant name separately; these may or may not be the same firm.