510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122973Substantially Equivalent

Al-106, Al-106Sa and Al-106B Medgyn Digital Video Colposcope

Medgyn Products, Inc., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122973 is the FDA 510(k) clearance record for AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE, a class II device, cleared for Medgyn Products, Inc. on under FDA product code HEX (Colposcope (And Colpomicroscope)). FDA records list 5 510(k) clearances for Medgyn Products, Inc., from to . As of , FDA records show no recalls naming K122973.

Clearance record

Decision date
Received
(259 days to decision)
Product code
HEX Colposcope (And Colpomicroscope)
Regulation
21 CFR 884.1630
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medgyn Products, Inc. 12 S. First Stree, San Jose 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