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FDA 510(k)

EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET

K-Number: K941731 · 1994-07-22

ApplicantIncutech, Inc.
Decision Date1994-07-22
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET is the device name listed in this FDA 510(k) record. The listed applicant is Incutech, Inc.. It received FDA 510(k) clearance on 1994-07-22 under 510(k) number K941731. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET?

EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET is a medical device that received FDA 510(k) clearance on 1994-07-22. The listed applicant is Incutech, Inc.. The 510(k) number is K941731.

When did EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET receive FDA 510(k) clearance?

EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET received FDA 510(k) clearance on 1994-07-22, under 510(k) number K941731.

Who is the listed applicant for EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET?

The FDA 510(k) record lists Incutech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET?

The FDA product code for EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET is KPE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Incutech, 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.

K960619MORE-L INJECTOR KIT PLUSK951870MORELL INJECTORK942394SAFE VENT SYSTEMK940258SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)

Related Devices (Code: KPE)

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.

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AGK252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd.

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.

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