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

Electrocautery, Gynecologic (And Accessories)

21 CFR 884.4120 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HGI is the FDA product code for Electrocautery, Gynecologic (And Accessories), a class II device type, regulated under 21 CFR 884.4120. As of , FDA records hold 53 510(k) clearances under this code, the most recent dated , and 24 recalls.

Classification record

Product code
HGI
Device name
Electrocautery, Gynecologic (And Accessories)
Regulation
21 CFR 884.4120
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
53
Ingested recalls
24

Clearances, product code HGI

By decision year
53 clearances under product code HGI with a decision year between 1977 and 2021, 1994 the highest year at 13.
Show the numbers
510(k) clearances under FDA product code HGI by decision year
YearClearances
19772
19901
19912
19926
19932
199413
19954
19965
19974
19981
19992
20002
20012
20021
20061
20071
20121
20141
20161
20211

Applicants with the most clearances

Product code HGI
Applicants holding the most 510(k) clearances under product code HGI
ApplicantClearances
CooperSurgical, Inc.8
Utah Medical Products, Inc4
Medtronic, Inc.3
Apyx Medical Corporation2
Aspen Labs2
Cabot Medical Corp.2
Cameron-Miller, Inc.2
Omni-Guide Holdings, Inc.2
Karl Storz Endoscopy-America, Inc.2
Liger Medical2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 48 companies shown, in name order