Product code HGL
- Device name
- Transducer, Ultrasonic, Obstetric
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.2960
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P800016S013 | TENNANT(TM) & KELMAN(TM) TYPE II | Bausch & Lomb, Inc. | 1990-03-19 |
| P800016S014 | YENNANT(TM) & KELMAN(TM) TYPE II | Bausch & Lomb, Inc. | 1989-12-11 |
| P800016S012 | TENNANT(TM) & KELMAN(TM) TYPE II | Bausch & Lomb, Inc. | 1989-03-02 |
| P800016S011 | TENNANT(TM) & KELMAN(TM) TYPE II | Bausch & Lomb, Inc. | 1988-05-09 |
| P800016S007 | TENNANT(TM) & KELMAN(TM) TYPE II | Bausch & Lomb, Inc. | 1986-06-13 |
| P800016S006 | TENNANT(TM) & KELMAN(TM) TYPE II | Bausch & Lomb, Inc. | 1986-01-08 |
| P800016S005 | TENNANT(TM) & KELMAN(TM) TYPE II | Bausch & Lomb, Inc. | 1985-07-25 |
| P800016S003 | TENNANT(TM) & KELMAN(TM) TYPE II | Bausch & Lomb, Inc. | 1985-06-28 |
| P800016S001 | TENNANT(TM) & KELMAN(TM) TYPE II | Bausch & Lomb, Inc. | 1983-05-25 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952031 | ULTRASOUND TRANSDUCER, MODEL US917 | Advanced Medical Systems, Inc. | 1995-07-18 |
| K923335 | ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION | Advanced Medical Systems, Inc. | 1994-07-22 |
| K924516 | OP3/VP4 | Huntleigh Technology, Inc. | 1993-06-28 |
| K903348 | ULTRASONIC PULSED DOPPLER IMAGING SYSTEM | Advanced Technology Laboratories, Inc. | 1990-10-22 |
| K900966 | EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE | Hitachi Medical Corp. of America | 1990-09-12 |
| K903316 | ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER | Ge Medical Systems Information Technologies | 1990-08-22 |
| K901142 | MER MULTIPLANE VAGINAL PROBE (MVP) | Medical Equipment Resources | 1990-08-22 |
| K900838 | TRANSVAGINAL TRANSDUCER ASSEMBLY | Pie Medical Equipment B.V. | 1990-05-23 |
| K895449 | ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM | Ge Medical Systems Information Technologies | 1990-03-05 |
| K881263 | MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER | Multigon Industries, Inc. | 1990-01-05 |
| K895647 | 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER | Advanced Technology Laboratories, Inc. | 1989-12-18 |
| K895123 | 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER | Advanced Technology Laboratories, Inc. | 1989-11-13 |
| K895026 | HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER | Hewlett-Packard Co. | 1989-11-06 |
| K894415 | DYMAX ENDOVAGINAL BIOPSY GUIDE | Dymax Corp | 1989-10-25 |
| K892070 | GENERAL IVT NEEDLE GUIDE KIT, STERILE | Amedic USA | 1989-09-05 |
| K881405 | SIEMENS INTRAVAGINAL TRANSDUCER | Siemens Medical Solutions USA, Inc. | 1988-08-02 |
| K875334 | KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM | Kontron Instruments, Inc. | 1988-03-24 |
| K875371 | KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM | Kontron Instruments, Inc. | 1988-03-24 |
| K872265 | ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE. | Labsonics, Inc. | 1988-01-04 |
| K871856 | ANNULAR ARRAY SCANHEAD | Advanced Technology Laboratories, Inc. | 1987-08-28 |
| K870709 | 7.5 MHZ ENDOVAGINAL PROBE | Philips Ultrasound, Inc. | 1987-03-27 |
| K864908 | DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE | Diasonics, Inc. | 1987-03-27 |
| K864578 | ACUSON TV519 TRANSDUCER | Acuson Computed Sonography | 1987-03-27 |
| K864219 | TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE | Amedic USA | 1987-03-27 |
| K864151 | 280SL IMAGING SYSTEM TRANVAGINAL PROBES | Ge Medical Systems Information Technologies | 1987-03-27 |
| K863797 | BIOPSY NEEDLE GUIDE ATTACHMENT | Elscint, Inc. | 1987-03-27 |
| K861371 | TRANSVAGINAL PROBE, MODEL ED65M-TV | Elscint, Inc. | 1986-07-14 |
| K862072 | FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01 | International Biomedics, Inc. | 1986-07-09 |
| K861577 | ACUSON S228, S519 & L558 TRANSDUCERS | Acuson Computed Sonography | 1986-06-19 |
| K861578 | ACUSON S328, L382, L538 & L312 TRANSDUCERS | Acuson Computed Sonography | 1986-06-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06944413812475 | Ultrasound Transducer | Edan Instruments, Inc. | 2025-11-04 |
| 06944413812482 | Ultrasound Transducer | Edan Instruments, Inc. | 2025-11-04 |
| 06944413812505 | Fetal & Maternal Module | Edan Instruments, Inc. | 2025-11-04 |
| 06944413812512 | Ultrasound Transducer | Edan Instruments, Inc. | 2025-11-04 |
| 06944413812529 | Ultrasound Transducer | Edan Instruments, Inc. | 2025-11-04 |
| 06944413812543 | Fetal & Maternal Module | Edan Instruments, Inc. | 2025-11-04 |
| 00857901006392 | UTAS | L K C TECHNOLOGIES, INC. | 2022-02-04 |
| 00884838093188 | Avalon Toco+ MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093201 | Avalon ECG/IUP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093218 | Avalon Toco MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093225 | Avalon Toco+ Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093195 | Avalon Ultrasound Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 05051968041265 | DOPPLEX | HUNTLEIGH HEALTHCARE LIMITED | 2020-02-17 |
| 05051968041272 | DOPPLEX | HUNTLEIGH HEALTHCARE LIMITED | 2020-02-17 |
| 06944413807242 | US Transducer | Edan Instruments, Inc. | 2018-10-19 |
| 00884838034242 | Avalon CL Ultrasound Transducer | Philips Medizin Systeme Böblingen GmbH | 2016-10-19 |
| 00884838002722 | Avalon US Transducer | Philips Medizin Systeme Böblingen GmbH | 2016-10-03 |
| 00884838021488 | Avalon Ultrasound Transducer USA | Philips Medizin Systeme Böblingen GmbH | 2016-10-03 |
| M745FM10835 | AIV | AMERICAN IV PRODUCTS, INC. | 2016-09-24 |
| 06944413807723 | Fetal monitor | Edan Instruments, Inc. | 2016-09-13 |
| 06944413806863 | Fetal monitor | Edan Instruments, Inc. | 2016-09-01 |
| 06944413800847 | Fetal Monitor | Edan Instruments, Inc. | 2016-09-01 |
| 06944413800861 | Fetal monitor | Edan Instruments, Inc. | 2016-09-01 |
| 06944413801820 | Fetal Telemetry System | Edan Instruments, Inc. | 2016-09-01 |
| 06944413805484 | US Transducer | Edan Instruments, Inc. | 2016-09-01 |
| 06944413805491 | US Transducer | Edan Instruments, Inc. | 2016-09-01 |
| 06944413805507 | TOCO Transducer | Edan Instruments, Inc. | 2016-09-01 |
| 06944413805514 | TOCO Transducer | Edan Instruments, Inc. | 2016-09-01 |
| 06944413805729 | NA | Edan Instruments, Inc. | 2016-09-01 |
| 05051968025265 | DOPPLEX | HUNTLEIGH HEALTHCARE LIMITED | 2016-08-25 |