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

Electrode, Circular (Spiral), Scalp And Applicator

21 CFR 884.2675 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HGP is the FDA product code for Electrode, Circular (Spiral), Scalp And Applicator, a class II device type, regulated under 21 CFR 884.2675. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
HGP
Device name
Electrode, Circular (Spiral), Scalp And Applicator
Regulation
21 CFR 884.2675
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
17
Ingested recalls
3

Clearances, product code HGP

By decision year
17 clearances under product code HGP with a decision year between 1977 and 2025, 1991 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code HGP by decision year
YearClearances
19771
19802
19831
19851
19872
19901
19915
19941
20011
20031
20251

Applicants with the most clearances

Product code HGP
Applicants holding the most 510(k) clearances under product code HGP
ApplicantClearances
Graphic Controls Corp.3
Clinical Innovations, LLC2
Medical Accessories, Inc.2
A.W. Showell (Surgicraft), Ltd.1
Advanced Medical Systems, Inc.1
Epcom Medical Systems, Inc.1
GE Medical Systems Information Technologies, Inc.1
Hewlett-Packard Co.1
Kontron Instruments, Inc.1
Life Support, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order