510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011840Substantially Equivalent

Cervilenz Uterine Measuring Sound

Cervilenz, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011840 is the FDA 510(k) clearance record for CERVILENZ UTERINE MEASURING SOUND, a class I device, cleared for Cervilenz, Inc. on under FDA product code HHM (Sound, Uterine). FDA records list one 510(k) clearance for Cervilenz, Inc. As of , FDA records show no recalls naming K011840.

Clearance record

Decision date
Received
(59 days to decision)
Product code
HHM Sound, Uterine
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Cervilenz, Inc. 2 Delphinus, Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code HHM

Trailing 12 months

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

FDA records show no clearances under product code HHM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HHM, 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