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FDA 510(k)

Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds

K-Number: K161358 · 2017-08-03

ApplicantSurgical Instrument Service and Savings, Inc.
Decision Date2017-08-03
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds 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 2017-08-03 under 510(k) number K161358. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds?

Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds is a medical device that received FDA 510(k) clearance on 2017-08-03. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K161358.

When did Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds received FDA 510(k) clearance on 2017-08-03, under 510(k) number K161358.

Who is the listed applicant for Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds?

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 Stryker Neptune 2 Manifolds?

The FDA product code for Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds is JCX.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerK252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic CatheterK250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic CatheterK250545Medline 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

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Related Devices (Code: JCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250964Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.K243638MV Flow Aspiration Pump (MVFLOWPMP01)MicroventionK251111CaryExcitus ASK243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. d/b/a ev3 NeurovascularK233428Easycess Aspiration PumpGuangzhou Easycess Medical Co.,LtdK222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)Stryker Instruments

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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