# Sophysa SA

- Location (FDA's records): Orsay, FR
- FDA decisions: 13 (2000–2026): 13 510(k) clearances
- Names in FDA's records: Sophysa SA (9); Sophysa (4)
- Product codes: JXG (10), GWM (3)
- 510(k) review time since 2016: median 265 days, against 195 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 21 (7 its own); citations of its devices by later devices: 12 (7 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Johnson & Johnson Professionals, Inc.: 5 (https://510kreport.com/company/johnson-johnson-professionals)
- Aesculap, Inc.: 2 (https://510kreport.com/company/aesculap)
- Raumedic AG: 2 (https://510kreport.com/company/raumedic)
- Holter-Hausner Intl.: 1 (https://510kreport.com/company/holter-hausner-intl)
- Codman & Shurtleff, Inc.: 1 (https://510kreport.com/company/codman-shurtleff)
- Intrgra Lifesciences Corporation: 1 (https://510kreport.com/company/intrgra-lifesciences)
- Integra LifeSciences Corporation: 1 (https://510kreport.com/company/integra-lifesciences)
- Cordis Corp.: 1 (https://510kreport.com/company/cordis)

## Firms that cite its devices most
- Raumedic AG: 2 (https://510kreport.com/company/raumedic)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)
- Medtronic PS Medical: 1 (https://510kreport.com/company/medtronic-ps-medical)
- Medos International SARL: 1 (https://510kreport.com/company/medos-international)

## Its most-cited devices
- K062584: Pressio Icp Monitoring System (2007), cited by 3
- K141227: Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve with Siphonx (2015), cited by 2
- K992465: Sophy SU8 Pressure Adjustable Valve (2000), cited by 2
- K013488: Sophy Pressure Adjustable Valve System Model SM8 (2002), cited by 1
- K090342: Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400 (2009), cited by 1
- K031097: Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVB (2004), cited by 1

## Recent decisions
- K252241: Pressio 3 Multi-parameter Neuromonitoring System (Apr 10, 2026)
- K250636: Sophy Mini Monopressure Valve (SM1) (Nov 28, 2025)
- K242974: External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters (Jun 20, 2025)
- K222422: Polaris Valve Electronic Reading Instrument (Feb 2, 2023)
- K162108: Pressio 2 ICP Monitoring System (Apr 17, 2017)
- K141227: Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve with Siphonx (Apr 2, 2015)
- K091328: Siphonx Gravitational Antisiphon Device (Jan 22, 2010)
- K090342: Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400 (Aug 11, 2009)

Source page: https://510kreport.com/company/sophysa