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)

U-STYLE ADAPTER

K-Number: K800735 · 1980-04-10

ApplicantAmerican Midwest
Decision Date1980-04-10
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

U-STYLE ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is American Midwest. It received FDA 510(k) clearance on 1980-04-10 under 510(k) number K800735. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U-STYLE ADAPTER?

U-STYLE ADAPTER is a medical device that received FDA 510(k) clearance on 1980-04-10. The listed applicant is American Midwest. The 510(k) number is K800735.

When did U-STYLE ADAPTER receive FDA 510(k) clearance?

U-STYLE ADAPTER received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800735.

Who is the listed applicant for U-STYLE ADAPTER?

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

What is the FDA product code for U-STYLE ADAPTER?

The FDA product code for U-STYLE ADAPTER is EGS.

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 American Midwest 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.

K821895AH-1 LIGHT-CURE DENTAL COMPOSITE RESTORK821715AM-40 SYSTEMK820693MIDWEST LIGHT WANDK811979ATT-1 DENTAL COMPOSITE RESTORATIVE SYS

Related Devices (Code: EGS)

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.

K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) LimitedK240950Disposable Prophy AnglePacific Care LimitedK240183Star E900 Handpiece SeriesDentalez, Inc., Stardental DivisionK230106General Cutting StraightNakanishi, Inc.K222518FX ContraNakanishi, Inc.K220874Smooth Drive contra angle and straight handpiecesLares Research

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.

↑