Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gyrus Medical , Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
405 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041285 | GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRO | Gyrus Medical , Ltd. | 2004-09-10 | 120 | 2 |
| K003569 | PLASMAKINETIC ENDOUROLOGY SYSTEM | Gyrus Medical , Ltd. | 2000-12-19 | 29 | 0 |
| K001270 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRO | Gyrus Medical , Ltd. | 2000-04-28 | 8 | 0 |
| K994166 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE | Gyrus Medical , Ltd. | 1999-12-27 | 18 | 0 |
| K993749 | GYRUS HYSTEROSCOPIC RESECTOSCOPE | Gyrus Medical , Ltd. | 1999-12-03 | 28 | 0 |
| K990628 | GYRUS ENDOUROLOGY SYSTEM | Gyrus Medical , Ltd. | 1999-06-29 | 124 | 0 |
| K982771 | GYRUS HYSTEROSCOPIC RESECTOSCOPE | Gyrus Medical , Ltd. | 1999-01-21 | 167 | 0 |
| K891681 | DILECTRON URINARY CONDUCTIVITY PROBE | Gyrus Medical , Ltd. | 1990-05-01 | 405 | 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