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FDA 510(k)

ASPIREX - BONE MARROW ASPIRATE KIT

K-Number: K041991 · 2004-09-16

ApplicantIsotis Orthobiologics, Inc.
Decision Date2004-09-16
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ASPIREX - BONE MARROW ASPIRATE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Isotis Orthobiologics, Inc.. It received FDA 510(k) clearance on 2004-09-16 under 510(k) number K041991. 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 ASPIREX - BONE MARROW ASPIRATE KIT?

ASPIREX - BONE MARROW ASPIRATE KIT is a medical device that received FDA 510(k) clearance on 2004-09-16. The listed applicant is Isotis Orthobiologics, Inc.. The 510(k) number is K041991.

When did ASPIREX - BONE MARROW ASPIRATE KIT receive FDA 510(k) clearance?

ASPIREX - BONE MARROW ASPIRATE KIT received FDA 510(k) clearance on 2004-09-16, under 510(k) number K041991.

Who is the listed applicant for ASPIREX - BONE MARROW ASPIRATE KIT?

The FDA 510(k) record lists Isotis Orthobiologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASPIREX - BONE MARROW ASPIRATE KIT?

The FDA product code for ASPIREX - BONE MARROW ASPIRATE KIT is FMF.

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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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