CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
FDA 510(k) clearance K981262 · decided 1998-07-06
Clearance details
- K-number
- K981262
- Device name
- CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
- Applicant
- Valleylab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-07
- Decision date
- 1998-07-06
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz recall (Z-1522-2014) | Integra LifeSciences Corp. | 2014-04-29 |
| Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for u recall (Z-0920-2013) | Integra LifeSciences Corp. | 2013-03-08 |
| Integra CUSA EXcel Sterile Tips Rx Only Single Use Only Product Usage: For usage in surgic recall (Z-1215-2012) | Integra LifeSciences Corp | 2012-03-15 |