510(k) K161853 ยท JXG Shunt, Central Nervous System And Components
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
| Applicant | Aesculap, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Feb 27, 2017 |
| Received | Jul 6, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161853
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2017 | Aesculap Implant Systems LLC proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System
Shunt, central nervous system and components Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.