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

System, Abortion, Vacuum

21 CFR 884.5070 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HHI is the FDA product code for System, Abortion, Vacuum, a class II device type, regulated under 21 CFR 884.5070. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
HHI
Device name
System, Abortion, Vacuum
Regulation
21 CFR 884.5070
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
24
Ingested recalls
2

Clearances, product code HHI

By decision year
24 clearances under product code HHI with a decision year between 1978 and 2017, 1984 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code HHI by decision year
YearClearances
19781
19802
19811
19831
19846
19851
19861
19873
19881
19903
19941
19981
20031
20171

Applicants with the most clearances

Product code HHI
Applicants holding the most 510(k) clearances under product code HHI
ApplicantClearances
Intl. Medical Technologies, Inc.4
Cosmedtech, Inc.3
Williams Specialty Products, Inc.2
Acmi Corporation1
American Hospital Supply1
Baxter Healthcare Corporation1
Berkeley Medevices1
Brooke Intl.1
Cooper Laboratories1
Cooper Medical Devices Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order