MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
FDA 510(k) clearance K022554 · decided 2002-08-23
Clearance details
- K-number
- K022554
- Device name
- MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
- Applicant
- Integra Neurosciences
- Decision
- Substantially Equivalent
- Date received
- 2002-08-02
- Decision date
- 2002-08-23
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- JXG
- Device class
- 2
- Regulation number
- 882.5550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Integra Neurosciences
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 |
|---|---|---|
| MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-1 recall (Z-1310-2019) | Integra LifeSciences Corp. | 2019-05-20 |
| MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: T recall (Z-1311-2019) | Integra LifeSciences Corp. | 2019-05-20 |