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)

KELLY-WICK TANNELER

K-Number: K830471 · 1983-03-24

ApplicantIntl. Medical Prosthetics Research
Decision Date1983-03-24
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KELLY-WICK TANNELER is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical Prosthetics Research. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830471. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KELLY-WICK TANNELER?

KELLY-WICK TANNELER is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Intl. Medical Prosthetics Research. The 510(k) number is K830471.

When did KELLY-WICK TANNELER receive FDA 510(k) clearance?

KELLY-WICK TANNELER received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830471.

Who is the listed applicant for KELLY-WICK TANNELER?

The FDA 510(k) record lists Intl. Medical Prosthetics Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KELLY-WICK TANNELER?

The FDA product code for KELLY-WICK TANNELER is DWS.

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

Related Devices (Code: DWS)

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.

K022238MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626Medtronic VascularK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)Dlp, Inc.K962771BURKE CONGENITAL THORACOSCOPY INSTRUMENTSPilling Weck, Inc.K955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAYContour Fabricators of Florida, Inc.K960139G.E. STERILE ANGIOGRAPHIC TRAYGE Medical SystemsK960144G.E. STERILE CT BIOPSY TRAYGE Medical Systems

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.

↑