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FDA 510(k)

PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS

K-Number: K052435 · 2005-11-03

ApplicantPneumrx, Inc.
Decision Date2005-11-03
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS is the device name listed in this FDA 510(k) record. The listed applicant is Pneumrx, Inc.. It received FDA 510(k) clearance on 2005-11-03 under 510(k) number K052435. 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 PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS?

PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS is a medical device that received FDA 510(k) clearance on 2005-11-03. The listed applicant is Pneumrx, Inc.. The 510(k) number is K052435.

When did PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS receive FDA 510(k) clearance?

PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS received FDA 510(k) clearance on 2005-11-03, under 510(k) number K052435.

Who is the listed applicant for PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS?

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

What is the FDA product code for PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS?

The FDA product code for PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS is KNW.

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Related Devices (Code: KNW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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