FDA 510(k)

PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES

K-Number: K011206 · 2001-07-18

Decision Date2001-07-18

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Parallax Medical, Inc.. It received FDA 510(k) clearance on 2001-07-18 under 510(k) number K011206. 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 PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES?

PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES is a medical device that received FDA 510(k) clearance on 2001-07-18. The listed applicant is Parallax Medical, Inc.. The 510(k) number is K011206.

When did PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES receive FDA 510(k) clearance?

PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES received FDA 510(k) clearance on 2001-07-18, under 510(k) number K011206.

Who is the listed applicant for PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES?

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

What is the FDA product code for PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES?

The FDA product code for PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES is KNW.

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Other records listing Parallax Medical, Inc. as applicant

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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.