HGLClass II

Transducer, Ultrasonic, Obstetric

21 CFR 884.2960 / Obstetrics/Gynecology

HGL is the FDA product code for Transducer, Ultrasonic, Obstetric, a class II device type, regulated under 21 CFR 884.2960. As of 2026-09-10, FDA records hold 36 510(k) clearances under this code, the most recent dated 1995-07-18, and 4 recalls.

Classification record

Product code: HGL
Device name: Transducer, Ultrasonic, Obstetric
Regulation: 21 CFR 884.2960
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: 36
Ingested recalls: 4

Clearances, product code HGL

By decision year

36 clearances under product code HGL with a decision year between 1977 and 1995, 1986 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code HGL by decision year
Year	Clearances
1977	2
1982	1
1986	7
1987	7
1988	4
1989	5
1990	7
1993	1
1994	1
1995	1

Applicants with the most clearances

Product code HGL

Applicants holding the most 510(k) clearances under product code HGL
Applicant	Clearances
Advanced Technology Laboratories, Inc.	4
Acuson Computed Sonography	3
GE Medical Systems Information Technologies, Inc.	3
Advanced Medical Systems, Inc.	2
Amedic USA	2
Elscint, Inc.	2
Kontron Instruments, Inc.	2
Philips North America LLC	2
Accusonics, Inc.	1
Diasonics, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order