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FDA 510(k)

MANAN PROSTATIC BIOPSY NEEDLE

K-Number: K895897 · 1989-10-18

ApplicantManan Medical Products, Inc.
Decision Date1989-10-18
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MANAN PROSTATIC BIOPSY NEEDLE 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 1989-10-18 under 510(k) number K895897. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANAN PROSTATIC BIOPSY NEEDLE?

MANAN PROSTATIC BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1989-10-18. The listed applicant is Manan Medical Products, Inc.. The 510(k) number is K895897.

When did MANAN PROSTATIC BIOPSY NEEDLE receive FDA 510(k) clearance?

MANAN PROSTATIC BIOPSY NEEDLE received FDA 510(k) clearance on 1989-10-18, under 510(k) number K895897.

Who is the listed applicant for MANAN PROSTATIC BIOPSY NEEDLE?

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 MANAN PROSTATIC BIOPSY NEEDLE?

The FDA product code for MANAN PROSTATIC BIOPSY NEEDLE is FCG.

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Other records listing Manan Medical Products, Inc. as applicant

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.

K052802MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLEK011209MANAN SPRITACRE SPINAL NEEDLESK983620MANAN SPINAL NEEDLESK980536EPIDURAL NEEDLEK981386MANAN BLUNT NEEDLEK980211MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES

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Related Devices (Code: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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