# DEN100026: Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with Endostaple Cassette, Aptus Endostaple Cassette

- Pathway: De Novo (Post-NSE)
- Applicant: Aptus Endosystems, Inc.
- Decided: Nov 21, 2011 after 342 days
- Product code: OTD (Endovascular Suturing System)
- Device class: 2
- Regulation: 21 CFR 870.3460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 5 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K121168: Aptus 18FR Helifx Guide-22 Deflectable Length (2012), 5 descendants of its own
- K130677: Aptus Heli-FX Aortic Securement System (2013), 4 descendants of its own
- K140036: Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable Length; Aptus Heli-FX Applier with (2014), 3 descendants of its own
- K141041: Aptus Heli-FX Ancillary Endoanchor Cassette (2014), 2 descendants of its own
- K171427: Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (2017), 1 descendant of its own

Source page: https://510kreport.com/device/DEN100026
Methodology: https://510kreport.com/methodology