510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K963593Substantially Equivalent

Imt Loupe-Colposcope

Inventive Medical Technology, Trappe MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963593 is the FDA 510(k) clearance record for IMT LOUPE-COLPOSCOPE, a class II device, cleared for Inventive Medical Technology on under FDA product code HEX (Colposcope (And Colpomicroscope)). FDA records list one 510(k) clearance for Inventive Medical Technology. As of , FDA records show no recalls naming K963593.

Clearance record

Decision date
Received
(225 days to decision)
Product code
HEX Colposcope (And Colpomicroscope)
Regulation
21 CFR 884.1630
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Inventive Medical Technology 4361 Baildon Rd., Trappe MD
510(k) summary
Summary
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