FDA applicant
Gyrus Ent LLC
FDA records 28 decisions for Gyrus Ent LLC (Bartlett, TN) from 1997 to 2004: 28 510(k) clearances. Most are in product codes ETB (Prosthesis, Partial Ossicular Replacement) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 25 predicates, 7 of them its own earlier devices. 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 Gyrus Ent LLC’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Gyrus Ent LLC since 2007.
Recalls per year
2in 2020
Class I Class II/III not classified
Planning a device like Gyrus Ent LLC’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 “Gyrus”
FDA records each applicant name separately; these may or may not be the same firm.