Origin Medsystems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
50
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K992353BLUNT TIP TROCAR PORTJuly 30, 1999
K981700VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEMMay 29, 1998
K972685ORIGIN LIGATOR DEVICEOctober 1, 1997
K970611ORIGIN CARDIAC STABLIZER OCCLUDERAugust 19, 1997
K965121CANNULAMarch 20, 1997
K964171VASOVIEW BALLOON DISSECTION SYSTEMFebruary 14, 1997
K962104AIRLIFT BALLOON RETRACTON SYSTEMSeptember 11, 1996
K962005EXTRAHAND BALLOON RETRACTORAugust 12, 1996
K960936RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]July 24, 1996
K9606375MM ENDOSCOPEJune 14, 1996
K955163DISSECTION PROBEJanuary 24, 1996
K954175DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES]November 9, 1995
K954174DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]November 9, 1995
K953377DISTENTION BALLOONOctober 23, 1995
K953561PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION)August 11, 1995
K946002ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRAJanuary 5, 1995
K944415ORIGIN TACKER SYSTEMNovember 28, 1994
K945023ORIGIN PIXIE STIC INTRODUCER SLEEVENovember 4, 1994
K944304ORIGIN BALLOON ANCHORSeptember 23, 1994
K942678LIFTING DISTENTION BALLOON SYSTEMJuly 8, 1994