FDA 510(k)

ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE

K-Number: K000612 · 2000-04-24

ApplicantInrad

Decision Date2000-04-24

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Inrad. It received FDA 510(k) clearance on 2000-04-24 under 510(k) number K000612. 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 ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE?

ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 2000-04-24. The listed applicant is Inrad. The 510(k) number is K000612.

When did ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE receive FDA 510(k) clearance?

ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE received FDA 510(k) clearance on 2000-04-24, under 510(k) number K000612.

Who is the listed applicant for ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE?

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

What is the FDA product code for ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE?

The FDA product code for ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE 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.