Vision-Sciences, Inc.: FDA clearances and approvals
Vision-Sciences, Inc. has 33 FDA 510(k) clearances (first 1986, latest 2011), across 9 product codes in 4 review panels. Median 510(k) review time: 76 days. openFDA lists 2 product recalls by a recalling firm named Vision-Sciences, Inc.
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 |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 15 | 15 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | 5 | 5 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 3 | 3 |
| EOX | Esophagoscope (Flexible Or Rigid) | 3 | 3 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 3 | 3 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
| HQG | Lens, Spectacle, Non-Custom (Prescription) | 1 | 1 |
Review panels
- Ear, Nose and Throat (21)
- Gastroenterology and Urology (10)
- Obstetrics and Gynecology (1)
- Ophthalmic (1)
Most recent Vision-Sciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102733 | VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR | EOB | 2011-05-18 | 238 |
| K100125 | VISION SCIENCES FLEXIBLE ENT SCOPE | EOB | 2010-02-25 | 37 |
| K091768 | VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES | EOQ | 2009-08-03 | 48 |
| K072180 | VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM | FAJ | 2007-12-18 | 134 |
| K071127 | FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM | HIH | 2007-11-16 | 207 |
| K072088 | FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS | EOX | 2007-08-29 | 30 |
| K072073 | VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR | EOB | 2007-08-29 | 30 |
| K071903 | ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE | EOX | 2007-08-02 | 23 |
| K053560 | MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE | FAJ | 2006-03-16 | 85 |
| K050972 | VISION-SCIENCES ENT-3000 SCOPE | EOB | 2005-04-29 | 11 |
23 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-12-27.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Vision-Sciences, Inc. have?
Vision-Sciences, Inc. has 33 FDA 510(k) clearances (first 1986, latest 2011), across 9 product codes in 4 review panels.
How long does FDA take to clear Vision-Sciences, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Vision-Sciences, Inc.'s cleared 510(k)s is 76 days.
What devices does Vision-Sciences, Inc. make?
Its most frequent FDA product codes are EOB (Nasopharyngoscope (Flexible Or Rigid), 15); FAM (Sigmoidoscope And Accessories, Flexible/Rigid, 5); EOQ (Bronchoscope (Flexible Or Rigid), 3).
Has Vision-Sciences, Inc. had device recalls?
openFDA lists 2 product recalls in 1 recall event by a recalling firm whose name matches Vision-Sciences, Inc; the most recent began 2011-12-27. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 33 Vision-Sciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EOB, Vision-Sciences, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.