510(k) K122619
K122619 is an FDA 510(k) premarket notification submitted by Applied Medical for the device "EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET". The FDA issued a decision of Substantially Equivalent on October 2, 2012. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Applied Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2012
- Date Received
- August 28, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type