ALEXIS LAPAROSCOPIC SYSTEM
FDA 510(k) clearance K093296 · decided 2009-11-05
Clearance details
- K-number
- K093296
- Device name
- ALEXIS LAPAROSCOPIC SYSTEM
- Applicant
- Applied Medical Resources Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-21
- Decision date
- 2009-11-05
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- KGW
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rancho Santa, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.