Vista Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Vista Medical Technologies, Inc.” (first 1995, latest 2002), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 71 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 | 5 | 5 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 1 | 1 |
Review panels
Most recent Vista Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021290 | VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100 | GCJ | 2002-06-28 | 66 |
| K020301 | MODIFICATION TO VISTA STEREOSCOPE SYSTEM | FET | 2002-02-12 | 14 |
| K991303 | VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE | GCJ | 1999-07-12 | 87 |
| K990635 | VISTA STEREOSCOPE SYSTEM | GCJ | 1999-05-19 | 82 |
| K973436 | VISTA HEAD MOUNTED DISPLAY | GCJ | 1997-12-09 | 90 |
| K971373 | VISTA SINGLE CHIP VIDEO CAMERA | FET | 1997-05-20 | 36 |
| K970217 | VISTA ILLUMINATION SYSTEM | FFS | 1997-04-02 | 71 |
| K961800 | HEAD MOUNTED DISPLAY | GCJ | 1996-09-11 | 125 |
| K953888 | TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE | EOB | 1995-10-07 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Vista Medical Technologies, Inc..
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.
- Vista Labs (2 510(k)s)
- Vista Lifesciences, Inc. (2 510(k)s)
- Vista AI, Inc. (1 510(k)s)
- Vista Industries,, LLC (1 510(k)s)
- Vista Laboratories, Inc. (1 510(k)s)
- Vista Med (1 510(k)s)
- Vista Medical Products, Inc. (1 510(k)s)
- Vista Ophthalmics, LLC (1 510(k)s)
- Vista Products, Inc. (1 510(k)s)
- Vista Scientific, LLC (1 510(k)s)
- Vista Vision (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vista Medical Technologies, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Vista Medical Technologies, Inc.” (first 1995, latest 2002), across 4 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 Vista Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vista Medical Technologies, Inc. is 71 days.
Which FDA product codes appear under Vista Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 5); FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 2); EOB (Nasopharyngoscope (Flexible Or Rigid), 1).
Next steps
- See all 9 Vista Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Vista Medical Technologies, 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.