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FDA 510(k)

SUCTION BIOPSY INSTRUMENT

K-Number: K895420 · 1990-02-09

ApplicantMill-Rose Laboratory
Decision Date1990-02-09
Product CodeFCK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUCTION BIOPSY INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Mill-Rose Laboratory. It received FDA 510(k) clearance on 1990-02-09 under 510(k) number K895420. The device is classified under product code FCK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUCTION BIOPSY INSTRUMENT?

SUCTION BIOPSY INSTRUMENT is a medical device that received FDA 510(k) clearance on 1990-02-09. The listed applicant is Mill-Rose Laboratory. The 510(k) number is K895420.

When did SUCTION BIOPSY INSTRUMENT receive FDA 510(k) clearance?

SUCTION BIOPSY INSTRUMENT received FDA 510(k) clearance on 1990-02-09, under 510(k) number K895420.

Who is the listed applicant for SUCTION BIOPSY INSTRUMENT?

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

What is the FDA product code for SUCTION BIOPSY INSTRUMENT?

The FDA product code for SUCTION BIOPSY INSTRUMENT is FCK.

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Other records listing Mill-Rose Laboratory 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.

K983122MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KITK983124MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KITK971275MILL-ROSE DISPOSABLE POLYPECTOMY SNAREK962736MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLEK960880MILL-ROSE BLIND MICROBIOLOGY BRUSHK954519WANG TRANSENDOSCOPIC ASPIRATION NEEDLE

View all 46 devices →

Related Devices (Code: FCK)

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.

K153763Howell Biliary Aspiration NeedleWilson-Cook Medical, Inc.K103326MULTIPLE BIOPSY SYSTEMUnited States Endoscopy Group, Inc.K062159RB12 SUCTION RECTAL BIOPSY SYSTEMAus Systems Pty , Ltd.K061201DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087United States Endoscopy Group, Inc.K051637DSNARE, MODEL 00711087United States Endoscopy Group, Inc.K954693MEHTA BRONCHIAL BIOSPY DRILLUnited States Endoscopy Group, Inc.

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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