Endo-Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Endo-Therapeutics, Inc.” (first 1993, latest 2009), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 114 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FCL | Forceps, Biopsy, Non-Electric | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KGE | Forceps, Biopsy, Electric | 1 | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 | 1 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 1 | 1 |
Review panels
Most recent Endo-Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090796 | MULTI-BITE HOT BIOPSY FORCEPS | KGE | 2009-11-25 | 246 |
| K031026 | ETI BIPOLAR HEMOSTATIC PROBE | KNS | 2003-06-27 | 88 |
| K023603 | ENDO-GLIDE GUIDEWIRE | OCY | 2003-02-19 | 114 |
| K012725 | TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES | GEI | 2001-11-08 | 85 |
| K012977 | VARICES INJECTION NEEDLE | FBK | 2001-11-02 | 58 |
| K926549 | ENDOCATH ELECTROPHYSIOLOGY CATHETER | DRF | 1993-12-06 | 340 |
| K925392 | BIOPSY FORCEPS | FCL | 1993-11-05 | 375 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-10-24.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Endo-Therapeutics, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Endo-Therapeutics, Inc.” (first 1993, latest 2009), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Endo-Therapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endo-Therapeutics, Inc. is 114 days.
Which FDA product codes appear under Endo-Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 1); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 1); FCL (Forceps, Biopsy, Non-Electric, 1).
Next steps
- See all 7 Endo-Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRF, Endo-Therapeutics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.