TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
FDA 510(k) clearance K020780 · decided 2002-05-20
Clearance details
- K-number
- K020780
- Device name
- TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
- Applicant
- Medex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-11
- Decision date
- 2002-05-20
- Days to decision
- 70 days
- Clearance type
- Abbreviated
- Product code
- GWM
- Device class
- 2
- Regulation number
- 882.1620
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Dublin, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medex
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2 recall (Z-0182-2025) | Smiths Medical ASD, Inc. | 2024-10-23 |
| medex TranStar Single ICP Set 1/EA, Product Code REF MX20897 recall (Z-0183-2025) | Smiths Medical ASD, Inc. | 2024-10-23 |