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)

MODEL MS-1 HANDPIECE

K-Number: K983413 · 1998-12-21

ApplicantParkell, Inc.
Decision Date1998-12-21
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODEL MS-1 HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 1998-12-21 under 510(k) number K983413. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL MS-1 HANDPIECE?

MODEL MS-1 HANDPIECE is a medical device that received FDA 510(k) clearance on 1998-12-21. The listed applicant is Parkell, Inc.. The 510(k) number is K983413.

When did MODEL MS-1 HANDPIECE receive FDA 510(k) clearance?

MODEL MS-1 HANDPIECE received FDA 510(k) clearance on 1998-12-21, under 510(k) number K983413.

Who is the listed applicant for MODEL MS-1 HANDPIECE?

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

What is the FDA product code for MODEL MS-1 HANDPIECE?

The FDA product code for MODEL MS-1 HANDPIECE is EKX.

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 Parkell, 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.

K243254Parkell Pit and Fissure SealantK210259Parkell Self-Adhesive CementK191103Parkell Desensitizer GelK190930SmarTemp X1K182296HyperFil-LVK172176Parkell Universal Adhesive

View all 50 devices →

Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

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.

↑