Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DIENER RETRIEVAL DEVICES

K-Number: K950559 · 1995-02-16

ApplicantMill-Rose Laboratory
Decision Date1995-02-16
Product CodeFCL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIENER RETRIEVAL DEVICES 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 1995-02-16 under 510(k) number K950559. The device is classified under product code FCL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIENER RETRIEVAL DEVICES?

DIENER RETRIEVAL DEVICES is a medical device that received FDA 510(k) clearance on 1995-02-16. The listed applicant is Mill-Rose Laboratory. The 510(k) number is K950559.

When did DIENER RETRIEVAL DEVICES receive FDA 510(k) clearance?

DIENER RETRIEVAL DEVICES received FDA 510(k) clearance on 1995-02-16, under 510(k) number K950559.

Who is the listed applicant for DIENER RETRIEVAL DEVICES?

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 DIENER RETRIEVAL DEVICES?

The FDA product code for DIENER RETRIEVAL DEVICES is FCL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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: FCL)

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.

K032092OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPEOlympus Optical Co., Ltd.K973611SPECTRASCIENCE REUSABLE BIOPSY FORCEPSSpectrascience, Inc.K971315AUXILIARY INSTRUMENTS FOR URSRichard Wolf Medical Instruments Corp.K964120INJECTO FLUSHRobert J. Jynch, Jr.K963517SPECTRA SCIENCE BIOPSY FORCEPSSpectrascience, Inc.K955065OLYMPUS FB SERIES BIOPSY FORCEPSOlympus America, 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.

↑