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 the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) 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. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K250314.

When did Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer receive FDA 510(k) clearance?

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

Who is the listed applicant for Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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Other records listing Surgical Instrument Service and Savings, Inc. as applicant

K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter K241156Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401

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Related Devices (Code: PNE)

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

Official Source

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