510(k) K093296
K093296 is an FDA 510(k) premarket notification submitted by Applied Medical Resources Corp. for the device "ALEXIS LAPAROSCOPIC SYSTEM". The FDA issued a decision of Substantially Equivalent on November 5, 2009. The device falls under product code KGW (Ring (Wound Protector), Drape Retention, Internal), a Class II device regulated under 21 CFR 878.4370. Applied Medical Resources Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2009
- Date Received
- October 21, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Ring (Wound Protector), Drape Retention, Internal
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- SU
- Submission Type