510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250034Unknown

Claria System

Claria Medical, Mountain View CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN250034 is the FDA 510(k) clearance record for Claria System, a class II device, cleared for Claria Medical, Inc. on under FDA product code SIM (Gynecologic Power Morcellator And Containment System). FDA's definition for product code SIM reads: "A gynecologic power morcellator and containment system is a prescription device consisting of an integrated power morcellator and a containment method that are intended to contain, reduce and remove gynecologic tissue that is not suspected...". FDA records list one 510(k) clearance for Claria Medical, Inc. As of , FDA records show no recalls naming DEN250034.

Clearance record

Decision date
Received
(329 days to decision)
Product code
SIM Gynecologic Power Morcellator And Containment System
Regulation
21 CFR 884.4075
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Claria Medical, Inc. 2586 Wyandotte St., Mountain View CA
Third party review
No

Clearances, product code SIM

Trailing 12 months
1 clearance under product code SIM in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SIM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260