510(k) K162437 ยท JXG Shunt, Central Nervous System And Components
Codman EDS3 CSF External Drainage System
| Applicant | Codman & Shurtleff, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Oct 28, 2016 |
| Received | Aug 31, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162437
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2024 | Natus Medical Incorporated External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only Open, Classified |
JXG | None listed |
| Jan 4, 2024 | Natus Medical Incorporated EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only Open, Classified |
JXG | None listed |
| Jan 12, 2021 | Natus Manufacturing Limited Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.