510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K122311Substantially Equivalent

Gc-3000E Digital Colposcope

Shenzhen Goldcare Meditech Co., Ltd., San Marino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122311 is the FDA 510(k) clearance record for GC-3000E DIGITAL COLPOSCOPE, a class II device, cleared for Shenzhen Goldcare Meditech Co., Ltd. on under FDA product code HEX (Colposcope (And Colpomicroscope)). FDA records list one 510(k) clearance for Shenzhen Goldcare Meditech Co., Ltd. As of , FDA records show no recalls naming K122311.

Clearance record

Decision date
Received
(413 days to decision)
Product code
HEX Colposcope (And Colpomicroscope)
Regulation
21 CFR 884.1630
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Shenzhen Goldcare Meditech Co., Ltd. 2600 Mission St., San Marino CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HEX

Trailing 12 months

FDA records hold no clearances under product code HEX in the trailing twelve months.

FDA records show no clearances under product code HEX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HEX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260