510(k) K111407
K111407 is an FDA 510(k) premarket notification submitted by Advanced Surgical Concepts for the device "TRIPORT, TRIPORT+, TRIPORT15, QUADPORT". The FDA issued a decision of Substantially Equivalent on January 18, 2012. The device falls under product code OTJ (Laparoscopic Single Port Access Device), a Class II device regulated under 21 CFR 876.1500. Advanced Surgical Concepts has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2012
- Date Received
- May 19, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscopic Single Port Access Device
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type
A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.