Suturtek Incorporated

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K082828SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICEOctober 14, 2008
K063603SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17February 7, 2007
K032468SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICESeptember 23, 2003
K030227SUTURTEK FASTCLOSE SUTURING DEVICEMarch 17, 2003