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FDA 510(k)

Insignis™ Syringe Infusion System

K-Number: K232328 · 2024-03-01

ApplicantInnovative Health Sciences, LLC
Decision Date2024-03-01
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Insignis™ Syringe Infusion System is a medical device manufactured by Innovative Health Sciences, LLC. It received FDA 510(k) clearance on 2024-03-01 under approval number K232328. 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™ Syringe Infusion System?

Insignis™ Syringe Infusion System is a medical device that received FDA 510(k) clearance on 2024-03-01. It is manufactured by Innovative Health Sciences, LLC. The 510(k) number is K232328.

When was Insignis™ Syringe Infusion System approved by the FDA?

Insignis™ Syringe Infusion System received FDA 510(k) clearance on 2024-03-01, under approval number K232328.

What company makes Insignis™ Syringe Infusion System?

Insignis™ Syringe Infusion System is manufactured by Innovative Health Sciences, LLC.

What is the FDA product code for Insignis™ Syringe Infusion System?

The FDA product code for Insignis™ Syringe Infusion System is FPA.

Related Clinical Trials

NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT06411054 The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA RECRUITING NCT07575191 Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer NOT_YET_RECRUITING NCT05286814 PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma RECRUITING NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING

Other Devices by Innovative Health Sciences, LLC

K202279Insignis Subcutaneous Needle Sets

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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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