510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940094Substantially Equivalent

Colposcopes and Accessories

Leisegang Medical, Inc., Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940094 is the FDA 510(k) clearance record for COLPOSCOPES AND ACCESSORIES, a class II device, cleared for Leisegang Medical, Inc. on under FDA product code HEX (Colposcope (And Colpomicroscope)). FDA records list 10 510(k) clearances for Leisegang Medical, Inc., from to . As of , FDA records show no recalls naming K940094.

Clearance record

Decision date
Received
(473 days to decision)
Product code
HEX Colposcope (And Colpomicroscope)
Regulation
21 CFR 884.1630
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Leisegang Medical, Inc. 6401 Congress Ave., Boca Raton FL
510(k) summary
Statement
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