MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
FDA 510(k) clearance K914479 · decided 1994-03-07
Clearance details
- K-number
- K914479
- Device name
- MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-08
- Decision date
- 1994-03-07
- Days to decision
- 881 days
- Clearance type
- Traditional
- Product code
- GWM
- Device class
- 2
- Regulation number
- 882.1620
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Randolph, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an int recall (Z-1614-2023) | Integra LifeSciences Corp. | 2023-05-19 |
| Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman C recall (Z-0706-2012) | Codman & Shurtleff, Inc. | 2012-01-11 |
| Codman Cranial Access Kit - complete with Xylocaine Product Code: 82-6614 Product Usage: T recall (Z-0707-2012) | Codman & Shurtleff, Inc. | 2012-01-11 |