510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220202Substantially Equivalent

Uterine ElevatOR PRO with OccludOR Balloon

The O R Company Pty, Ltd., Carrum Downs, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220202 is the FDA 510(k) clearance record for Uterine ElevatOR PRO with OccludOR Balloon, a class II device, cleared for The O R Company Pty, Ltd. on under FDA product code LKF (Cannula, Manipulator/Injector, Uterine). FDA records list 2 510(k) clearances for The O R Company Pty, Ltd., from to . As of , FDA records show no recalls naming K220202.

Clearance record

Decision date
Received
(66 days to decision)
Product code
LKF Cannula, Manipulator/Injector, Uterine
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
The O R Company Pty, Ltd. 1/32 Silkwood Rise, Carrum Downs, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LKF

Trailing 12 months
2 clearances under product code LKF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LKF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260