510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K070845Substantially Equivalent

Sounmed Coloposcope Colpo-99/99Plus

Sounmed, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070845 is the FDA 510(k) clearance record for SOUNMED COLOPOSCOPE COLPO-99/99PLUS, a class II device, cleared for Sounmed, Inc. on under FDA product code HEX (Colposcope (And Colpomicroscope)). FDA records list 2 510(k) clearances for Sounmed, Inc., from to . As of , FDA records show no recalls naming K070845.

Clearance record

Decision date
Received
(199 days to decision)
Product code
HEX Colposcope (And Colpomicroscope)
Regulation
21 CFR 884.1630
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sounmed, Inc. 6800 NW 77th. Ct., Miami FL
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