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

by Aptus Endosystems, Inc.

De Novo DEN100026

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Post-NSE NumberDEN100026 Date21 Nov 2011DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
OTD
Device Class
Class II
Regulation
21 CFR Part 870.3460
Advisory Committee
Cardiovascular
FDA Decision
DENG De Novo granted

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aptus Steerable Endoguide With Obturator, Aptus Endostaple Applier With Endostaple Cassette, and Aptus Endostaple Cassette form an Endovascular Suturing System designed for cardiovascular procedures. This system includes a steerable endoguide with obturator, an endostaple applier with cassette, and a separate endostaple cassette component.

The device is supplied as a single-use system and is regulated under FDA 510(k) clearance with product code OTD. It is intended for use in cardiovascular applications and is classified as Class II medical device. The system includes model number DEN100026 and was cleared by Aptus Endosystems, Inc. on November 21, 2011.

Other devices from Aptus Endosystems, Inc.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Aptus Steerable Endoguide with Obturator, Endostaple Applier with Cassette, and Endostaple Cassette used for?

    This system is designed for cardiovascular procedures as an Endovascular Suturing System, intended to assist in suturing within vascular anatomy during surgical interventions.

  • How is the Aptus Endovascular Suturing System supplied and is it reusable?

    The system is supplied as a single-use device, meaning each component—the steerable endoguide with obturator, endostaple applier with cassette, and separate endostaple cassette—is intended for one procedure only and should not be reprocessed or reused.

  • What regulatory pathway was used for the Aptus Endovascular Suturing System and what is its product code?

    The device received FDA 510(k) clearance under product code OTD, with the submission tracked under k-number DEN100026, and was cleared on November 21, 2011.