Sophysa SA: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Sophysa SA” (first 2000, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 262 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 | 1 | 325 |
| 2016 | 0 | — |
| 2017 | 1 | 262 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sophysa SA took a median 262 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 7 | 7 |
| GWM | Device, Monitoring, Intracranial Pressure | 2 | 2 |
Review panels
- Neurology (9)
Most recent Sophysa SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162108 | Pressio 2 ICP Monitoring System | GWM | 2017-04-17 | 262 |
| K141227 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX | JXG | 2015-04-02 | 325 |
| K091328 | SIPHONX GRAVITATIONAL ANTISIPHON DEVICE | JXG | 2010-01-22 | 262 |
| K090342 | POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 | JXG | 2009-08-11 | 182 |
| K062584 | PRESSIO ICP MONITORING SYSTEM | GWM | 2007-07-05 | 307 |
| K042481 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 | JXG | 2004-12-14 | 92 |
| K031097 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB | JXG | 2004-02-26 | 325 |
| K013488 | SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 | JXG | 2002-03-27 | 159 |
| K992465 | SOPHY SU8 PRESSURE ADJUSTABLE VALVE | JXG | 2000-09-21 | 426 |
Recalls
openFDA lists no recalls under a recalling firm named Sophysa SA.
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.
- Sophysa (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sophysa SA?
FDA lists 9 510(k) clearances under the applicant name “Sophysa SA” (first 2000, latest 2017), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sophysa SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sophysa SA is 262 days.
Which FDA product codes appear under Sophysa SA?
The most frequent FDA product codes under this applicant name are JXG (Shunt, Central Nervous System And Components, 7); GWM (Device, Monitoring, Intracranial Pressure, 2).
Next steps
- See all 9 Sophysa SA clearances with predicates and recalls
- Run predicate analysis for product code JXG, Sophysa SA'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.