FDA 510(k)

BIOPSY INTRODUCER NEEDLE

K-Number: K963390 · 1996-10-10

Decision Date1996-10-10

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BIOPSY INTRODUCER NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1996-10-10 under 510(k) number K963390. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY INTRODUCER NEEDLE?

BIOPSY INTRODUCER NEEDLE is a medical device that received FDA 510(k) clearance on 1996-10-10. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K963390.

When did BIOPSY INTRODUCER NEEDLE receive FDA 510(k) clearance?

BIOPSY INTRODUCER NEEDLE received FDA 510(k) clearance on 1996-10-10, under 510(k) number K963390.

Who is the listed applicant for BIOPSY INTRODUCER NEEDLE?

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

What is the FDA product code for BIOPSY INTRODUCER NEEDLE?

The FDA product code for BIOPSY INTRODUCER NEEDLE is KNW.

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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.