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

Screw, Fibroid, Gynecological

21 CFR 884.4530 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HHO is the FDA product code for Screw, Fibroid, Gynecological, a class II device type, regulated under 21 CFR 884.4530. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HHO
Device name
Screw, Fibroid, Gynecological
Regulation
21 CFR 884.4530
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
2
Ingested recalls
0

Clearances, product code HHO

By decision year
2 clearances under product code HHO with a decision year between 1992 and 1992, 1992 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HHO by decision year
YearClearances
19922

Applicants with the most clearances

Product code HHO
Applicants holding the most 510(k) clearances under product code HHO
ApplicantClearances
Cook Incorporated2

Companies listing this code with FDA

Companies whose registered establishments list this code