FDA 510(k)

MANAN(TM) SUPER-CORE BIOPSY NEEDLES

K-Number: K974814 · 1998-01-09

ApplicantMedical Device Technologies, Inc.

Decision Date1998-01-09

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MANAN(TM) SUPER-CORE BIOPSY NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Technologies, Inc.. It received FDA 510(k) clearance on 1998-01-09 under 510(k) number K974814. 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 MANAN(TM) SUPER-CORE BIOPSY NEEDLES?

MANAN(TM) SUPER-CORE BIOPSY NEEDLES is a medical device that received FDA 510(k) clearance on 1998-01-09. The listed applicant is Medical Device Technologies, Inc.. The 510(k) number is K974814.

When did MANAN(TM) SUPER-CORE BIOPSY NEEDLES receive FDA 510(k) clearance?

MANAN(TM) SUPER-CORE BIOPSY NEEDLES received FDA 510(k) clearance on 1998-01-09, under 510(k) number K974814.

Who is the listed applicant for MANAN(TM) SUPER-CORE BIOPSY NEEDLES?

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

What is the FDA product code for MANAN(TM) SUPER-CORE BIOPSY NEEDLES?

The FDA product code for MANAN(TM) SUPER-CORE BIOPSY NEEDLES is KNW.

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Related Devices (Code: 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.