FDA applicant
Synergetics, Inc.
FDA records 18 decisions for Synergetics, Inc. (O' Fallon, MO) from 1992 to 2016: 18 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and MPA (Endoilluminator). Its devices cite 12 predicates, 4 of them its own earlier devices. 25 recalls are linked to its devices.
FDA’s records also spell it “Synergetics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Synergetics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
19in 2023
Class I Class II/III not classified
Planning a device like Synergetics, 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) Report