Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Advanced Energy, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132974 | AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, | Medtronic Advanced Energy, LLC | 2013-12-03 | 71 | 0 |
| K123201 | AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER | Medtronic Advanced Energy, LLC | 2013-01-10 | 90 | 0 |
| K120909 | EC 2.7 ENDOSCOPIC CUTTER | Medtronic Advanced Energy, LLC | 2012-11-02 | 221 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda