# Aptus Endosystems, Inc.

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 5 (2011–2014): 4 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Aptus Endosystems, Inc. (4); Aptus Endosystems (1)
- Product codes: OTD (5)
- Predicates its devices cite: 10 (10 its own); citations of its devices by later devices: 15 (10 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Medtronic Vascular: 5 (https://510kreport.com/company/medtronic-vascular)

## Its most-cited devices
- DEN100026: Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with Endostaple Cassette, Aptus Endostaple Cassette (2011), cited by 5
- K121168: Aptus 18FR Helifx Guide-22 Deflectable Length (2012), cited by 4
- K130677: Aptus Heli-FX Aortic Securement System (2013), cited by 3
- K140036: Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable Length; Aptus Heli-FX Applier with (2014), cited by 2
- K141041: Aptus Heli-FX Ancillary Endoanchor Cassette (2014), cited by 1

## Recent decisions
- K141041: Aptus Heli-FX Ancillary Endoanchor Cassette (May 16, 2014)
- K140036: Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable Length; Aptus Heli-FX Applier with (Feb 6, 2014)
- K130677: Aptus Heli-FX Aortic Securement System (Apr 12, 2013)
- K121168: Aptus 18FR Helifx Guide-22 Deflectable Length (Aug 8, 2012)
- DEN100026: Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with Endostaple Cassette, Aptus Endostaple Cassette (Nov 21, 2011)

Source page: https://510kreport.com/company/aptus-endosystems