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FDA 510(k)

Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer

K-Number: K250314 · 2025-12-19

ApplicantSurgical Instrument Service and Savings, Inc.
Decision Date2025-12-19
Product CodePNE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer is a medical device manufactured by Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2025-12-19 under approval number K250314. The device is classified under product code PNE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer?

Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Surgical Instrument Service and Savings, Inc.. The 510(k) number is K250314.

When was Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer approved by the FDA?

Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer received FDA 510(k) clearance on 2025-12-19, under approval number K250314.

What company makes Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer?

Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer is manufactured by Surgical Instrument Service and Savings, Inc..

What is the FDA product code for Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer?

The FDA product code for Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer is PNE.

Related Clinical Trials

NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING NCT06223789 VOLT-AF IDE Clinical Study COMPLETED

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Related Devices (Code: PNE)

K152090Reprocessed Steerable IntroducerSterilmed, Inc. K170311Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC K212165Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLC K230376Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathInnovative Health, LLC K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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