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FDA 510(k)

PLEURA BIOPSY DEVICE

K-Number: K901995 · 1990-07-10

ApplicantMill-Rose Laboratory
Decision Date1990-07-10
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLEURA BIOPSY DEVICE 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 1990-07-10 under 510(k) number K901995. The device is classified under product code GDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLEURA BIOPSY DEVICE?

PLEURA BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 1990-07-10. The listed applicant is Mill-Rose Laboratory. The 510(k) number is K901995.

When did PLEURA BIOPSY DEVICE receive FDA 510(k) clearance?

PLEURA BIOPSY DEVICE received FDA 510(k) clearance on 1990-07-10, under 510(k) number K901995.

Who is the listed applicant for PLEURA BIOPSY DEVICE?

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 PLEURA BIOPSY DEVICE?

The FDA product code for PLEURA BIOPSY DEVICE is GDM.

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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

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Related Devices (Code: GDM)

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.

K071732MARROWMINERStemcor Systems, Inc.K971114BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K953082ILIAC CREST BONE MARROW ASPIRATION NEEDLEBaxter Healthcare CorpK953064BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K936207ENDO-NEEDLE INSTRUMENTGerard Medical, Inc.K930160ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLESymbiosis Corp.

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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