Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endolap, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
249 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974516 | ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE | Endolap, Inc. | 1997-12-22 | 20 | 0 |
| K974515 | ENDOLAP RESECTOSCOPE ROLLER ELECTRODE | Endolap, Inc. | 1997-12-22 | 20 | 0 |
| K950243 | TITAN INSUFFLATION NEEDLE | Endolap, Inc. | 1995-04-06 | 76 | 0 |
| K950219 | ENDOLAP INSUFFLATOR TUBING SET | Endolap, Inc. | 1995-03-23 | 63 | 0 |
| K933492 | ESYS SYSTEM | Endolap, Inc. | 1994-03-25 | 249 | 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