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

Amniotome

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

HGE is the FDA product code for Amniotome, a class I device type, regulated under 21 CFR 884.4530. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HGE
Device name
Amniotome
Regulation
21 CFR 884.4530
Device class
Class I
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
6
Ingested recalls
0

Clearances, product code HGE

By decision year
6 clearances under product code HGE with a decision year between 1983 and 1995, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HGE by decision year
YearClearances
19831
19851
19871
19911
19941
19951

Applicants with the most clearances

Product code HGE
Applicants holding the most 510(k) clearances under product code HGE
ApplicantClearances
Epcom Medical Systems, Inc.1
Go Medical Industries Pty., Ltd.1
Imm Enterprises, Ltd.1
Onli1
Raymart Development Co.1
Salt Creek Medical Technologies1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 40 companies shown, in name order