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FDA 510(k)

HIgH-Flo Super26 Subcutaneous Needle Sets

K-Number: K180843 · 2019-04-04

ApplicantRepro-Med Systems, Inc. Dba Rms Medical Products
Decision Date2019-04-04
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HIgH-Flo Super26 Subcutaneous Needle Sets is a medical device manufactured by Repro-Med Systems, Inc. Dba Rms Medical Products. It received FDA 510(k) clearance on 2019-04-04 under approval number K180843. 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 HIgH-Flo Super26 Subcutaneous Needle Sets?

HIgH-Flo Super26 Subcutaneous Needle Sets is a medical device that received FDA 510(k) clearance on 2019-04-04. It is manufactured by Repro-Med Systems, Inc. Dba Rms Medical Products. The 510(k) number is K180843.

When was HIgH-Flo Super26 Subcutaneous Needle Sets approved by the FDA?

HIgH-Flo Super26 Subcutaneous Needle Sets received FDA 510(k) clearance on 2019-04-04, under approval number K180843.

What company makes HIgH-Flo Super26 Subcutaneous Needle Sets?

HIgH-Flo Super26 Subcutaneous Needle Sets is manufactured by Repro-Med Systems, Inc. Dba Rms Medical Products.

What is the FDA product code for HIgH-Flo Super26 Subcutaneous Needle Sets?

The FDA product code for HIgH-Flo Super26 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

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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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