SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
FDA 510(k) clearance K021989 · decided 2002-09-13
Clearance details
- K-number
- K021989
- Device name
- SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
- Applicant
- Integra Neurosciences
- Decision
- Substantially Equivalent
- Date received
- 2002-06-18
- Decision date
- 2002-09-13
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Ster recall (Z-0431-06) | Integra LifeSciences Corp. | 2006-01-24 |
| Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz recall (Z-0141-06) | Integra LifeSciences Corp. | 2005-11-16 |