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FDA 510(k)

Insignis Subcutaneous Needle Sets

K-Number: K202279 · 2021-08-13

ApplicantInnovative Health Sciences, LLC
Decision Date2021-08-13
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Insignis Subcutaneous Needle Sets is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health Sciences, LLC. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K202279. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Insignis Subcutaneous Needle Sets?

Insignis Subcutaneous Needle Sets is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Innovative Health Sciences, LLC. The 510(k) number is K202279.

When did Insignis Subcutaneous Needle Sets receive FDA 510(k) clearance?

Insignis Subcutaneous Needle Sets received FDA 510(k) clearance on 2021-08-13, under 510(k) number K202279.

Who is the listed applicant for Insignis Subcutaneous Needle Sets?

The FDA 510(k) record lists Innovative Health Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insignis Subcutaneous Needle Sets?

The FDA product code for Insignis Subcutaneous Needle Sets is FPA.

Other records listing Innovative Health Sciences, LLC 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.

K232328Insignis™ Syringe Infusion System

Related Devices (Code: FPA)

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.

K261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)K251814EZ™ IV Administration SetEpic 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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