Medivision Scope Service Center, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medivision Scope Service Center, Inc.” (first 1997, latest 1999), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 65 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 |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
Review panels
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent Medivision Scope Service Center, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984434 | MEDIVISION LAPAROSCOPE | GCJ | 1999-03-17 | 93 |
| K982659 | MEDIVISION HYSTEROSCOPE | HIH | 1998-10-07 | 69 |
| K982620 | MEDIVISION CYSTOSCOPE | FAJ | 1998-09-30 | 65 |
| K971996 | MEDIVISION ARTHROSCOP | HRX | 1997-07-31 | 62 |
| K971995 | MEDIVISION SINOSCOPE | EOB | 1997-06-26 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Medivision Scope Service Center, 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.
- Medivision Medical Imaging, Ltd. (4 510(k)s)
- Medivision Endoscopy (1 510(k)s)
- Medivision (U.S.A.), Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medivision Scope Service Center, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Medivision Scope Service Center, Inc.” (first 1997, latest 1999), across 5 product codes in 5 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 Medivision Scope Service Center, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medivision Scope Service Center, Inc. is 65 days.
Which FDA product codes appear under Medivision Scope Service Center, Inc.?
The most frequent FDA product codes under this applicant name are EOB (Nasopharyngoscope (Flexible Or Rigid), 1); FAJ (Cystoscope And Accessories, Flexible/Rigid, 1); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 5 Medivision Scope Service Center, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EOB, Medivision Scope Service Center, 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.