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

Heater, Perineal, Direct Contact

21 CFR 884.5390 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HGZ is the FDA product code for Heater, Perineal, Direct Contact, a class II device type, regulated under 21 CFR 884.5390. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
HGZ
Device name
Heater, Perineal, Direct Contact
Regulation
21 CFR 884.5390
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code HGZ

By decision year
1 clearance under product code HGZ with a decision year between 1994 and 1994, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HGZ by decision year
YearClearances
19941

Applicants with the most clearances

Product code HGZ
Applicants holding the most 510(k) clearances under product code HGZ
ApplicantClearances
Medtronic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code