meddevicedb.com FDA Device Reference

GC-3000E DIGITAL COLPOSCOPE

K122311 Class II Traditional
Decision Date
2013-09-18
Sponsor / Applicant
Shenzhen Goldcare Meditech Co., Ltd.

Technical Specification

510(k) Submission ID K122311
Product Code HEX
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.1630
Decision Date 2013-09-18
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

GC-3000E DIGITAL COLPOSCOPE received FDA 510(k) clearance under submission number K122311, sponsored by Shenzhen Goldcare Meditech Co., Ltd.. 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 2013-09-18.

Classification & Regulation

This clearance is catalogued under FDA product code HEX and 21 CFR 884.1630, within the Obstetrics/Gynecology review panel as a Class II device.