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

Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)

21 CFR 884.1300 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HES is the FDA product code for Insufflator, Carbon-Dioxide, Uterotubal (And Accessories), a class II device type, regulated under 21 CFR 884.1300. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HES
Device name
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Regulation
21 CFR 884.1300
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
13
Ingested recalls
0

Clearances, product code HES

By decision year
13 clearances under product code HES with a decision year between 1984 and 2014, 1990 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HES by decision year
YearClearances
19841
19851
19861
19871
19881
19892
19904
20001
20141

Applicants with the most clearances

Product code HES
Applicants holding the most 510(k) clearances under product code HES
ApplicantClearances
Adler Instrument Company2
Bionexus, Inc.1
C.R. Bard Inc1
Cabot Medical Corp.1
Medtronic, Inc.1
Cook Ob/Gyn1
Core Dynamics, Inc.1
F.M. Wiest USA, Inc.1
Humi Corp.1
Rocket Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code