Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Greenwald Surgical Co., Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933173 | GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE | Greenwald Surgical Co., Inc. | 1994-04-01 | 276 | 0 |
| K933175 | GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE | Greenwald Surgical Co., Inc. | 1994-04-01 | 276 | 0 |
| K933174 | GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE | Greenwald Surgical Co., Inc. | 1994-04-01 | 276 | 0 |
| K780137 | CLAMP, INCONTINENCE, BAUMRUCKER | Greenwald Surgical Co., Inc. | 1978-04-28 | 93 | 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