510(k) DEN100026

APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE by Aptus Endosystems, Inc. — Product Code OTD

DEN100026 is an FDA 510(k) premarket notification submitted by Aptus Endosystems, Inc. for the device "APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE". The FDA issued a decision of De Novo Granted on November 21, 2011. The device falls under product code OTD (Endovascular Suturing System), a Class II device regulated under 21 CFR 870.3460. Aptus Endosystems, Inc. has at least 4 other 510(k) clearances on record.