FDA 510(k)

MRI COMPATIBLE BIOPSY NEEDLES

K-Number: K962977 · 1997-10-09

Decision Date1997-10-09

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MRI COMPATIBLE BIOPSY NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Manan Medical Products, Inc.. It received FDA 510(k) clearance on 1997-10-09 under 510(k) number K962977. 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 MRI COMPATIBLE BIOPSY NEEDLES?

MRI COMPATIBLE BIOPSY NEEDLES is a medical device that received FDA 510(k) clearance on 1997-10-09. The listed applicant is Manan Medical Products, Inc.. The 510(k) number is K962977.

When did MRI COMPATIBLE BIOPSY NEEDLES receive FDA 510(k) clearance?

MRI COMPATIBLE BIOPSY NEEDLES received FDA 510(k) clearance on 1997-10-09, under 510(k) number K962977.

Who is the listed applicant for MRI COMPATIBLE BIOPSY NEEDLES?

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

What is the FDA product code for MRI COMPATIBLE BIOPSY NEEDLES?

The FDA product code for MRI COMPATIBLE BIOPSY NEEDLES is KNW.

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Other records listing Manan Medical Products, Inc. as applicant

K052802MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE K011209MANAN SPRITACRE SPINAL NEEDLES K983620MANAN SPINAL NEEDLES K980536EPIDURAL NEEDLE K981386MANAN BLUNT NEEDLE K980211MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES

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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.