Endotherapeutics: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Endotherapeutics” (first 1984, latest 1987), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 54 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 | 1 |
| FBQ | Trocar, Gastro-Urology | 1 | 1 |
| FHO | Pneumoperitoneum Needle | 1 | 1 |
| FHP | Needle, Pneumoperitoneum, Simple | 1 | 1 |
| GCP | Endoscope, Ac-Powered And Accessories | 1 | 1 |
Review panels
Most recent Endotherapeutics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870855 | UROSCAN | FAP | 1987-06-09 | 98 |
| K860192 | ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE | HET | 1986-03-17 | 54 |
| K860103 | MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE | GCP | 1986-02-12 | 33 |
| K860102 | MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE | FHP | 1986-02-12 | 33 |
| K852031 | ENDOPORT 5MM | HET | 1985-08-13 | 96 |
| K844619 | ENDONEEDLE | FHO | 1985-01-09 | 43 |
| K841716 | ENDOPORT EROCAR | FBQ | 1984-06-28 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Endotherapeutics.
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 Endotherapeutics?
FDA lists 7 510(k) clearances under the applicant name “Endotherapeutics” (first 1984, latest 1987), across 6 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 Endotherapeutics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endotherapeutics is 54 days.
Which FDA product codes appear under Endotherapeutics?
The most frequent FDA product codes under this applicant name are HET (Laparoscope, Gynecologic (And Accessories), 2); FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 1); FBQ (Trocar, Gastro-Urology, 1).
Next steps
- See all 7 Endotherapeutics clearances with predicates and recalls
- Run predicate analysis for product code HET, Endotherapeutics'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.