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ADT PERCUTANEOUS NON-DISP. NEEDLE

K800420 Class II Traditional
Decision Date
1980-03-25
Sponsor / Applicant
A.D.T. Lab Industries

Technical Specification

510(k) Submission ID K800420
Product Code FCG
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.1075
Decision Date 1980-03-25
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

ADT PERCUTANEOUS NON-DISP. NEEDLE received FDA 510(k) clearance under submission number K800420, sponsored by A.D.T. Lab Industries. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1980-03-25.

Classification & Regulation

This clearance is catalogued under FDA product code FCG and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.