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)

RNG SERIES ULTRASOUND NEEDLE/CATH. GDS

K-Number: K820269 · 1982-03-23

ApplicantCIVCO Medical Instruments Co., Inc.
Decision Date1982-03-23
Product CodeDWO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RNG SERIES ULTRASOUND NEEDLE/CATH. GDS is the device name listed in this FDA 510(k) record. The listed applicant is CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 1982-03-23 under 510(k) number K820269. The device is classified under product code DWO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RNG SERIES ULTRASOUND NEEDLE/CATH. GDS?

RNG SERIES ULTRASOUND NEEDLE/CATH. GDS is a medical device that received FDA 510(k) clearance on 1982-03-23. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K820269.

When did RNG SERIES ULTRASOUND NEEDLE/CATH. GDS receive FDA 510(k) clearance?

RNG SERIES ULTRASOUND NEEDLE/CATH. GDS received FDA 510(k) clearance on 1982-03-23, under 510(k) number K820269.

Who is the listed applicant for RNG SERIES ULTRASOUND NEEDLE/CATH. GDS?

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

What is the FDA product code for RNG SERIES ULTRASOUND NEEDLE/CATH. GDS?

The FDA product code for RNG SERIES ULTRASOUND NEEDLE/CATH. GDS is DWO.

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 CIVCO Medical Instruments Co., 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.

K260114Align® Cover and Pad Guidance ToolK231783VitroPROK222052VitroPROK211270CIV-Clear coverK163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorK160806Verza Guidance System

View all 30 devices →

Related Devices (Code: DWO)

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.

K933364PROMED BIOPSY NEEDLEVlv Associates, Inc.K921418ULTRA-CORE BIOPSY NEEDLESMedical Device Technologies, Inc.K913815AUTOMATED BIOPSY DEVICE, MODIFICATIONHart Enterprises, Inc.K890925MANAN BONE MARROW BIOPSY NEEDLEManan Medical Products, Inc.K885145MEDSURG GREENE NEEDLEMedsurg Industries, Inc.K885149NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICEHart Enterprises, 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.

↑