CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
FDA 510(k) clearance K061568 · decided 2006-09-29
Clearance details
- K-number
- K061568
- Device name
- CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-06-06
- Decision date
- 2006-09-29
- Days to decision
- 115 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Codman & Shurtleff
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog recall (Z-0089-2015) | Codman & Shurtleff, Inc. | 2014-10-20 |
| Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog recall (Z-0090-2015) | Codman & Shurtleff, Inc. | 2014-10-20 |
| Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Numbe recall (Z-0091-2015) | Codman & Shurtleff, Inc. | 2014-10-20 |