Codman EDS3 CSF External Drainage System
FDA 510(k) clearance K162437 · decided 2016-10-28
Clearance details
- K-number
- K162437
- Device name
- Codman EDS3 CSF External Drainage System
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-08-31
- Decision date
- 2016-10-28
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- JXG
- Device class
- 2
- Regulation number
- 882.5550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only recall (Z-0634-2024) | Natus Medical Incorporated | 2024-01-04 |
| EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only recall (Z-0635-2024) | Natus Medical Incorporated | 2024-01-04 |