meddevicedb.com FDA Device Reference

ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)

K942986 Class II Traditional
Decision Date
1995-03-21
Sponsor / Applicant
Aaron Medical Industries

Technical Specification

510(k) Submission ID K942986
Product Code HGI
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.4120
Decision Date 1995-03-21
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP) received FDA 510(k) clearance under submission number K942986, sponsored by Aaron Medical Industries. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1995-03-21.

Classification & Regulation

This clearance is catalogued under FDA product code HGI and 21 CFR 884.4120, within the Obstetrics/Gynecology review panel as a Class II device.