510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
HGSClass II

Catheter, Intrauterine And Introducer

21 CFR 884.2700 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HGS is the FDA product code for Catheter, Intrauterine And Introducer, a class II device type, regulated under 21 CFR 884.2700. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HGS
Device name
Catheter, Intrauterine And Introducer
Regulation
21 CFR 884.2700
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
2
Ingested recalls
1

Clearances, product code HGS

By decision year
2 clearances under product code HGS with a decision year between 1991 and 1991, 1991 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HGS by decision year
YearClearances
19912

Applicants with the most clearances

Product code HGS
Applicants holding the most 510(k) clearances under product code HGS
ApplicantClearances
Epcom Medical Systems, Inc.1
Telos Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code