Endomedix: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Endomedix” (first 1992, latest 1994), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 135 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 |
|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HBI | Illuminator, Fiberoptic, Surgical Field | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 | 1 |
Review panels
Most recent Endomedix 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934170 | ENDOMEDIX Y-ADAPTER | OCX | 1994-01-11 | 137 |
| K934623 | ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA | FET | 1993-12-02 | 66 |
| K930499 | GRASPING FORCEPS FLEXIBLE STONE DISLODGER | OCZ | 1993-08-16 | 196 |
| K930349 | STONE RETRIEVAL BASKET | FFL | 1993-06-09 | 135 |
| K926004 | ENDOSCOPE AND ACCOSSORIES | FGB | 1993-02-10 | 75 |
| K922837 | S1500 XENON LIGHT SOURCE | HBI | 1992-11-03 | 144 |
| K922082 | LAPAROSCOPIC INTRODUCER | GCJ | 1992-08-03 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Endomedix.
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 Endomedix?
FDA lists 7 510(k) clearances under the applicant name “Endomedix” (first 1992, latest 1994), across 7 product codes in 2 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 Endomedix?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endomedix is 135 days.
Which FDA product codes appear under Endomedix?
The most frequent FDA product codes under this applicant name are FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 1); FFL (Dislodger, Stone, Basket, Ureteral, Metal, 1); FGB (Ureteroscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 7 Endomedix clearances with predicates and recalls
- Run predicate analysis for product code FET, Endomedix'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.