Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

aboNT SYRINGE

K-Number: K212677 · 2022-04-15

Decision Date2022-04-15
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

aboNT SYRINGE is a medical device manufactured by Nipro Medical Corporation. It received FDA 510(k) clearance on 2022-04-15 under approval number K212677. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the aboNT SYRINGE?

aboNT SYRINGE is a medical device that received FDA 510(k) clearance on 2022-04-15. It is manufactured by Nipro Medical Corporation. The 510(k) number is K212677.

When was aboNT SYRINGE approved by the FDA?

aboNT SYRINGE received FDA 510(k) clearance on 2022-04-15, under approval number K212677.

What company makes aboNT SYRINGE?

aboNT SYRINGE is manufactured by Nipro Medical Corporation.

What is the FDA product code for aboNT SYRINGE?

The FDA product code for aboNT SYRINGE is FMF.

Other Devices by Nipro Medical Corporation

View all 11 devices →

Related Devices (Code: FMF)

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.