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)

JGH1 Core Deccompression Procedure Kit

K-Number: K181585 · 2018-07-20

Decision Date2018-07-20
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JGH1 Core Deccompression Procedure Kit is a medical device manufactured by AgNovos Healthcare USA, LLC. It received FDA 510(k) clearance on 2018-07-20 under approval number K181585. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JGH1 Core Deccompression Procedure Kit?

JGH1 Core Deccompression Procedure Kit is a medical device that received FDA 510(k) clearance on 2018-07-20. It is manufactured by AgNovos Healthcare USA, LLC. The 510(k) number is K181585.

When was JGH1 Core Deccompression Procedure Kit approved by the FDA?

JGH1 Core Deccompression Procedure Kit received FDA 510(k) clearance on 2018-07-20, under approval number K181585.

What company makes JGH1 Core Deccompression Procedure Kit?

JGH1 Core Deccompression Procedure Kit is manufactured by AgNovos Healthcare USA, LLC.

What is the FDA product code for JGH1 Core Deccompression Procedure Kit?

The FDA product code for JGH1 Core Deccompression Procedure Kit is MQV.

Other Devices by AgNovos Healthcare USA, LLC

Related Devices (Code: MQV)

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.