510(k) Report

De Novo · Granted

Granted

Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with Endostaple Cassette, Aptus Endostaple Cassette

DEN100026De NovoGranted Nov 21, 2011342-day reviewClass II21 CFR 870.3460

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aptus Endosystems, Inc. · OTD Endovascular Suturing System

Granted on Nov 21, 2011 as a new device type through De Novo after a 342-day review. 6 later devices descend from it.

Decided
Nov 21, 2011
Review
342 days
Class
Class II
Product code
OTD
Recalls
None

6 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2014: 2 descendants cleared2017: 1 descendant cleared2013: 1 descendant cleared2012: 1 descendant cleared2018: 1 descendant cleared2010201520202025
  1. This deviceDEN100026 Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier…Aptus Endosystems, Inc. · 2011
  2. Descendant · cites it directly · 5 of its ownK121168 Aptus 18FR Helifx Guide-22 Deflectable LengthAptus Endosystems, Inc. · 2012
  3. Descendant · cites it directly · 4 of its ownK130677 Aptus Heli-FX Aortic Securement SystemAptus Endosystems, Inc. · 2013
  4. Descendant · cites it directly · 3 of its ownK140036 Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide -…Aptus Endosystems, Inc. · 2014
  5. Descendant · cites it directly · 2 of its ownK141041 Aptus Heli-FX Ancillary Endoanchor CassetteAptus Endosystems · 2014
  6. Descendant · cites it directly · 1 of its ownK171427 Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc. · 2017 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 22017: 12018: 1
2012high 2 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 6 · See all
  • K121168Aptus 18FR Helifx Guide-22 Deflectable LengthAptus Endosystems, Inc. · 2012 · cites it directly5descendants
  • K130677Aptus Heli-FX Aortic Securement SystemAptus Endosystems, Inc. · 2013 · cites it directly4descendants
  • K140036Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable…Aptus Endosystems, Inc. · 2014 · cites it directly3descendants
  • K141041Aptus Heli-FX Ancillary Endoanchor CassetteAptus Endosystems · 2014 · cites it directly2descendants
  • K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc. · 2017 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)DEN100026Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with…Aptus Endosystems, Inc.2011—
+1K121168Aptus 18FR Helifx Guide-22 Deflectable LengthAptus Endosystems, Inc.2012—
+1K130677Aptus Heli-FX Aortic Securement SystemAptus Endosystems, Inc.2013—
+1K140036Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM…Aptus Endosystems, Inc.2014—
+1K141041Aptus Heli-FX Ancillary Endoanchor CassetteAptus Endosystems2014—
+1K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc.20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201420
201710
201810
FIG. 1 — Lineage of DEN100026, 2011–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OTD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (6)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121168Aptus 18FR Helifx Guide-22 Deflectable LengthAptus Endosystems, Inc.20125
K130677Aptus Heli-FX Aortic Securement SystemAptus Endosystems, Inc.20134
K140036Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable…Aptus Endosystems, Inc.20143
K141041Aptus Heli-FX Ancillary Endoanchor CassetteAptus Endosystems20142
K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc.20171

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K121168 (Aptus Endosystems, Inc., 2012) has gone furthest, with 5 descendants of its own.

How does its category compare?

All OTD devices

OTD Endovascular Suturing System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OTD

1in 2018

2011: 12012: 12013: 12014: 22017: 12018: 1
2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTD

Too few OTD 510(k)s in any year since 2007 to give a median.

Recalls per year · OTD

No recall names OTD since 2007.

Adverse event reports per year · OTD

53in 2025

2012: 12013: 52014: 162015: 722016: 1662017: 1612018: 2152019: 1412020: 1012021: 592022: 522023: 522024: 622025: 53
2007high 215 (2018) · low 0 (2007)2025

MAUDE reports naming product code OTD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—00
20121—01
20131—05
20142—016
20150—072
20160—0166
20171—0161
20181—0215
20190—0141
20200—0101
20210—059
20220—052
20230—052
20240—062
20250—053
20260—0—

More from Aptus Endosystems, Inc.

4 FDA decisions under this applicant name. See the company

  • K140036Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable Length; Aptus Heli-FX…Aptus Endosystems, Inc. · 2014
  • K130677Aptus Heli-FX Aortic Securement SystemAptus Endosystems, Inc. · 2013
  • K121168Aptus 18FR Helifx Guide-22 Deflectable LengthAptus Endosystems, Inc. · 2012

Recent decisions in OTD

The OTD category page

  • K182957Heli-FX EndoAnchor SystemMedtronic Vascular, Inc. · 2018
  • K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc. · 20171 recall
  • K141041Aptus Heli-FX Ancillary Endoanchor CassetteAptus Endosystems · 2014
  • K140036Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable Length; Aptus Heli-FX…Aptus Endosystems, Inc. · 2014
  • K130677Aptus Heli-FX Aortic Securement SystemAptus Endosystems, Inc. · 2013

https://510kreport.com/device/DEN100026 · printed Nov 4, 2026

Cite this page

510(k) Report. “DEN100026: Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with Endostaple Cassette, Aptus Endostaple Cassette.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN100026

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026