Endovations: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “Endovations” (first 1986, latest 1996), across 17 product codes in 3 review panels. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 14 | 14 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 4 | 4 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 2 | 2 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | 2 | 2 |
| OCX | Endoscopic Irrigation/Suction System | 2 | 2 |
| DYN | Mouthpiece, Saliva Ejector | 1 | 1 |
| EZB | Stylet For Catheter, Gastro-Urology | 1 | 1 |
| FCF | Instrument, Biopsy, Mechanical, Gastrointestinal | 1 | 1 |
Plus 7 more product codes.
Review panels
Most recent Endovations 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955413 | ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER | FGE | 1996-02-08 | 73 |
| K942110 | INJECT-SNARE | FDI | 1994-10-13 | 164 |
| K944049 | OXYGEN MOUTHGUARD | MNK | 1994-10-11 | 54 |
| K934315 | ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME | KNS | 1994-02-28 | 180 |
| K913841 | 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH | FGE | 1991-10-08 | 43 |
| K913870 | 5MM MICROSCISSORS | GCJ | 1991-09-16 | 18 |
| K911155 | OVAL CUP BIOPSY FORCEP | FCF | 1991-08-07 | 145 |
| K892218 | ENDO-SPONGE | MNL | 1989-05-31 | 58 |
| K883093 | TRANSENDOSCOPIC ASPIRATION NEEDLE | FBK | 1988-12-08 | 139 |
| K873360 | ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG | KNT | 1988-03-30 | 222 |
28 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Endovations.
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 Endovations?
FDA lists 38 510(k) clearances under the applicant name “Endovations” (first 1986, latest 1996), across 17 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 Endovations?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endovations is 89 days.
Which FDA product codes appear under Endovations?
The most frequent FDA product codes under this applicant name are OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered, 14); FGE (Stents, Drains And Dilators For The Biliary Ducts, 4); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 2).
Next steps
- See all 38 Endovations clearances with predicates and recalls
- Run predicate analysis for product code OCZ, Endovations'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.