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FDA 510(k)

XTRACT SYRINGE KEY SYSTEM

K-Number: K112475 · 2011-11-10

ApplicantXtract Solutions
Decision Date2011-11-10
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

XTRACT SYRINGE KEY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xtract Solutions. It received FDA 510(k) clearance on 2011-11-10 under 510(k) number K112475. 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 XTRACT SYRINGE KEY SYSTEM?

XTRACT SYRINGE KEY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-10. The listed applicant is Xtract Solutions. The 510(k) number is K112475.

When did XTRACT SYRINGE KEY SYSTEM receive FDA 510(k) clearance?

XTRACT SYRINGE KEY SYSTEM received FDA 510(k) clearance on 2011-11-10, under 510(k) number K112475.

Who is the listed applicant for XTRACT SYRINGE KEY SYSTEM?

The FDA 510(k) record lists Xtract Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XTRACT SYRINGE KEY SYSTEM?

The FDA product code for XTRACT SYRINGE KEY SYSTEM is FMF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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