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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 a medical device manufactured by Innovative Health Sciences, LLC. It received FDA 510(k) clearance on 2021-08-13 under approval 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. It is manufactured by Innovative Health Sciences, LLC. The 510(k) number is K202279.

When was Insignis Subcutaneous Needle Sets approved by the FDA?

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

What company makes Insignis Subcutaneous Needle Sets?

Insignis Subcutaneous Needle Sets is manufactured by Innovative Health Sciences, LLC.

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

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

Related Clinical Trials

NCT07607249 Clinical Study on the Treatment of Gastrointestinal Dysfunction After Knee Joint Surgery Under General Anesthesia With Floating Needle ENROLLING_BY_INVITATION

Other Devices by Innovative Health Sciences, LLC

K232328Insignis™ Syringe Infusion System

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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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