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

Applicator, Vaginal

21 CFR 884.4520 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HGD is the FDA product code for Applicator, Vaginal, a class I device type, regulated under 21 CFR 884.4520. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 2 recalls.

Classification record

Product code
HGD
Device name
Applicator, Vaginal
Regulation
21 CFR 884.4520
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
1
Ingested recalls
2

Clearances, product code HGD

By decision year
1 clearance under product code HGD with a decision year between 1983 and 1983, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HGD by decision year
YearClearances
19831

Applicants with the most clearances

Product code HGD
Applicants holding the most 510(k) clearances under product code HGD
ApplicantClearances
Kline Technologies, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 59 companies shown, in name order