510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973746Substantially Equivalent

Pre-Filled Syringe for Koala Iup

Clinical Innovations, LLC, Murray UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973746 is the FDA 510(k) clearance record for PRE-FILLED SYRINGE FOR KOALA IUP, a class II device, cleared for Clinical Innovations, Inc. on under FDA product code HFN (Transducer, Pressure, Intrauterine). FDA records list 18 510(k) clearances for Clinical Innovations, Inc., from to . As of , FDA records show no recalls naming K973746.

Clearance record

Decision date
Received
(54 days to decision)
Product code
HFN Transducer, Pressure, Intrauterine
Regulation
21 CFR 884.2700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Clinical Innovations, Inc. 6477 S. Cottonwood St., Murray UT
510(k) summary
Summary
Third party review
No

Clearances, product code HFN

Trailing 12 months

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

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