CRW-1 SYSTEM
FDA 510(k) clearance K944463 · decided 1995-10-26
Clearance details
- K-number
- K944463
- Device name
- CRW-1 SYSTEM
- Applicant
- Radionics Software Applications, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-12
- Decision date
- 1995-10-26
- Days to decision
- 409 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact H recall (Z-0025-2016) | Integra LifeSciences Corp. | 2015-10-06 |
| Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly recall (Z-2428-2012) | Integra LifeSciences Corporation | 2012-09-20 |
| Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is use recall (Z-2429-2012) | Integra LifeSciences Corporation | 2012-09-20 |
| Integra Radionics HRAIM Intubation Head Ring Assembly Ref: HRAIM Head Rings serve as the g recall (Z-1400-2011) | Integra LifeSciences Corp. | 2011-02-23 |