Envision Medical Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Envision Medical Corp.” (first 1994, latest 1997), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 93 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| FWB | Camera, Television, Surgical, Without Audio | 1 | 1 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 1 |
Review panels
Most recent Envision Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970605 | 3-CCD DIGITAL CAMERA | GCJ | 1997-05-22 | 93 |
| K953438 | SURGICAL INTEGRATED CAMERA SYSTEM | GCJ | 1995-11-06 | 108 |
| K951971 | XENON LIGHT SOURCE | GCT | 1995-05-24 | 27 |
| K944707 | ISOLATED CAMERA HEAD | FWF | 1994-10-07 | 14 |
| K934092 | CAMERA, SURGICAL AND ACCESSORIES | FWB | 1994-01-07 | 137 |
Recalls
openFDA lists no recalls under a recalling firm named Envision Medical Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Envision Surgical System, Inc. (3 510(k)s)
- Envision, Inc. (2 510(k)s)
- Envision Endoscopy (2 510(k)s)
- Envision Advanced Medical System, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Envision Medical Corp.?
FDA lists 5 510(k) clearances under the applicant name “Envision Medical Corp.” (first 1994, latest 1997), across 4 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 Envision Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Envision Medical Corp. is 93 days.
Which FDA product codes appear under Envision Medical Corp.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 2); FWB (Camera, Television, Surgical, Without Audio, 1); FWF (Camera, Television, Endoscopic, Without Audio, 1).
Next steps
- See all 5 Envision Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Envision Medical Corp.'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.