Product Code: HGL FDA class 2 21 CFR 884.2960

Transducer, Ultrasonic, Obstetric

Obstetrics/Gynecology

The Obstetric Ultrasonic Transducer is a device that converts electrical energy into ultrasonic waves and receives reflected echoes for diagnostic imaging of the uterus, fetus, and pelvic structures during obstetric examinations. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HGL, regulated under 21 CFR 884.2960, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code HGL in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: HGL
Device Class: FDA class 2
Regulation Number: 884.2960
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K952031	ULTRASOUND TRANSDUCER, MODEL US917	Jul 18, 1995	Substantially Equivalent	Advanced Medical Systems, Inc.
K923335	ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION	Jul 22, 1994	Substantially Equivalent	Advanced Medical Systems, Inc.
K924516	OP3/VP4	Jun 28, 1993	Substantially Equivalent	Huntleigh Technology, Inc.
K903348	ULTRASONIC PULSED DOPPLER IMAGING SYSTEM	Oct 22, 1990	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K900966	EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE	Sep 12, 1990	Substantially Equivalent	Hitachi Medical Corp. of America
K903316	ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER	Aug 22, 1990	Substantially Equivalent	Ge Medical Systems Information Technologies
K901142	MER MULTIPLANE VAGINAL PROBE (MVP)	Aug 22, 1990	Substantially Equivalent	Medical Equipment Resources
K900838	TRANSVAGINAL TRANSDUCER ASSEMBLY	May 23, 1990	Substantially Equivalent	Pie Medical Equipment B.V.
K895449	ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM	Mar 05, 1990	Substantially Equivalent	Ge Medical Systems Information Technologies
K881263	MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER	Jan 05, 1990	Substantially Equivalent	Multigon Industries, Inc.
K895647	5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER	Dec 18, 1989	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K895123	5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER	Nov 13, 1989	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K895026	HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER	Nov 06, 1989	Substantially Equivalent	Hewlett-Packard Co.
K894415	DYMAX ENDOVAGINAL BIOPSY GUIDE	Oct 25, 1989	Substantially Equivalent	Dymax Corp
K892070	GENERAL IVT NEEDLE GUIDE KIT, STERILE	Sep 05, 1989	Substantially Equivalent	Amedic USA
K881405	SIEMENS INTRAVAGINAL TRANSDUCER	Aug 02, 1988	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K875371	KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM	Mar 24, 1988	Substantially Equivalent	Kontron Instruments, Inc.
K875334	KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM	Mar 24, 1988	Substantially Equivalent	Kontron Instruments, Inc.
K872265	ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.	Jan 04, 1988	Substantially Equivalent	Labsonics, Inc.
K871856	ANNULAR ARRAY SCANHEAD	Aug 28, 1987	Substantially Equivalent for Some Indications	Advanced Technology Laboratories, Inc.
K870709	7.5 MHZ ENDOVAGINAL PROBE	Mar 27, 1987	Substantially Equivalent	Philips Ultrasound, Inc.
K864908	DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE	Mar 27, 1987	Substantially Equivalent	Diasonics, Inc.
K864578	ACUSON TV519 TRANSDUCER	Mar 27, 1987	Substantially Equivalent	Acuson Computed Sonography
K864219	TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE	Mar 27, 1987	Substantially Equivalent	Amedic USA
K864151	280SL IMAGING SYSTEM TRANVAGINAL PROBES	Mar 27, 1987	Substantially Equivalent	Ge Medical Systems Information Technologies
K863797	BIOPSY NEEDLE GUIDE ATTACHMENT	Mar 27, 1987	Substantially Equivalent	Elscint, Inc.
K861371	TRANSVAGINAL PROBE, MODEL ED65M-TV	Jul 14, 1986	Substantially Equivalent	Elscint, Inc.
K862072	FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01	Jul 09, 1986	Substantially Equivalent	International Biomedics, Inc.
K861577	ACUSON S228, S519 & L558 TRANSDUCERS	Jun 19, 1986	Substantially Equivalent	Acuson Computed Sonography
K861578	ACUSON S328, L382, L538 & L312 TRANSDUCERS	Jun 17, 1986	Substantially Equivalent	Acuson Computed Sonography
K860234	TRANSVAGINAL TRANSDUCER, 5MHZ	May 23, 1986	Substantially Equivalent	Philips Medical Systems, Inc.
K860621	1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507	May 20, 1986	Substantially Equivalent	Impex Medical Systems, Inc.
K860313	3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031	Mar 17, 1986	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K827885	BIO-DERM COUPLING LOTION	Jan 29, 1982	Substantially Equivalent	Whs Products, Inc.
K771869	DIAG. ULTRASOUND B-SCANNER	Nov 02, 1977	Substantially Equivalent	Accusonics, Inc.
K771151	ARTIUS SYSTEM	Aug 04, 1977	Substantially Equivalent	General Electric Co.