510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
HHJClass II

Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic

21 CFR 884.2225 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HHJ is the FDA product code for Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic, a class II device type, regulated under 21 CFR 884.2225. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
HHJ
Device name
Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
Regulation
21 CFR 884.2225
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code HHJ

By decision year
1 clearance under product code HHJ with a decision year between 2002 and 2002, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HHJ by decision year
YearClearances
20021

Applicants with the most clearances

Product code HHJ
Applicants holding the most 510(k) clearances under product code HHJ
ApplicantClearances
Ultraguide, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code HHJ.