Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endo-Therapeutics, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
114 daysmedian FDA review time
375 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090796 | MULTI-BITE HOT BIOPSY FORCEPS | Endo-Therapeutics, Inc. | 2009-11-25 | 246 | 0 |
| K031026 | ETI BIPOLAR HEMOSTATIC PROBE | Endo-Therapeutics, Inc. | 2003-06-27 | 88 | 0 |
| K023603 | ENDO-GLIDE GUIDEWIRE | Endo-Therapeutics, Inc. | 2003-02-19 | 114 | 0 |
| K012725 | TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR | Endo-Therapeutics, Inc. | 2001-11-08 | 85 | 0 |
| K012977 | VARICES INJECTION NEEDLE | Endo-Therapeutics, Inc. | 2001-11-02 | 58 | 0 |
| K926549 | ENDOCATH ELECTROPHYSIOLOGY CATHETER | Endo-Therapeutics, Inc. | 1993-12-06 | 340 | 0 |
| K925392 | BIOPSY FORCEPS | Endo-Therapeutics, Inc. | 1993-11-05 | 375 | 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