510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864219Substantially Equivalent

Transvaginal Ultrasound Biopsy Needle Guide

Amedic USA, Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864219 is the FDA 510(k) clearance record for TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE, a class II device, cleared for Amedic USA on under FDA product code HGL (Transducer, Ultrasonic, Obstetric). FDA records list 10 510(k) clearances for Amedic USA, from to . As of , FDA records show no recalls naming K864219.

Clearance record

Decision date
Received
(150 days to decision)
Product code
HGL Transducer, Ultrasonic, Obstetric
Regulation
21 CFR 884.2960
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Amedic USA 3702 E. Roeser Rd., Suite, Phoenix AZ
Third party review
No

Clearances, product code HGL

Trailing 12 months

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

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