FDA Product Code
FDA Product Code HGL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2960
510(k) Clearances — 36 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K952031 | ULTRASOUND TRANSDUCER, MODEL US917 | Advanced Medical Systems, Inc. | 1995-07-18 | Traditional | PDF ↗ |
| K923335 | ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION | Advanced Medical Systems, Inc. | 1994-07-22 | Traditional | PDF ↗ |
| K924516 | OP3/VP4 | Huntleigh Technology, Inc. | 1993-06-28 | Traditional | PDF ↗ |
| K903348 | ULTRASONIC PULSED DOPPLER IMAGING SYSTEM | Advanced Technology Laboratories, Inc. | 1990-10-22 | Traditional | PDF ↗ |
| K900966 | EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE | Hitachi Medical Corp. of America | 1990-09-12 | Traditional | PDF ↗ |
| K903316 | ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER | Ge Medical Systems Information Technologies | 1990-08-22 | Traditional | PDF ↗ |
| K901142 | MER MULTIPLANE VAGINAL PROBE (MVP) | Medical Equipment Resources | 1990-08-22 | Traditional | PDF ↗ |
| K900838 | TRANSVAGINAL TRANSDUCER ASSEMBLY | Pie Medical Equipment B.V. | 1990-05-23 | Traditional | PDF ↗ |
| K895449 | ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM | Ge Medical Systems Information Technologies | 1990-03-05 | Traditional | PDF ↗ |
| K881263 | MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER | Multigon Industries, Inc. | 1990-01-05 | Traditional | PDF ↗ |
| K895647 | 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER | Advanced Technology Laboratories, Inc. | 1989-12-18 | Traditional | PDF ↗ |
| K895123 | 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER | Advanced Technology Laboratories, Inc. | 1989-11-13 | Traditional | PDF ↗ |
| K895026 | HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER | Hewlett-Packard Co. | 1989-11-06 | Traditional | PDF ↗ |
| K894415 | DYMAX ENDOVAGINAL BIOPSY GUIDE | Dymax Corp | 1989-10-25 | Traditional | PDF ↗ |
| K892070 | GENERAL IVT NEEDLE GUIDE KIT, STERILE | Amedic USA | 1989-09-05 | Traditional | PDF ↗ |
| K881405 | SIEMENS INTRAVAGINAL TRANSDUCER | Siemens Medical Solutions USA, Inc. | 1988-08-02 | Traditional | PDF ↗ |
| K875334 | KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM | Kontron Instruments, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K875371 | KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM | Kontron Instruments, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K872265 | ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE. | Labsonics, Inc. | 1988-01-04 | Traditional | PDF ↗ |
| K871856 | ANNULAR ARRAY SCANHEAD | Advanced Technology Laboratories, Inc. | 1987-08-28 | Traditional | PDF ↗ |
| K863797 | BIOPSY NEEDLE GUIDE ATTACHMENT | Elscint, Inc. | 1987-03-27 | Traditional | PDF ↗ |
| K870709 | 7.5 MHZ ENDOVAGINAL PROBE | Philips Ultrasound, Inc. | 1987-03-27 | Traditional | PDF ↗ |
| K864908 | DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE | Diasonics, Inc. | 1987-03-27 | Traditional | PDF ↗ |
| K864219 | TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE | Amedic USA | 1987-03-27 | Traditional | PDF ↗ |
| K864578 | ACUSON TV519 TRANSDUCER | Acuson Computed Sonography | 1987-03-27 | Traditional | PDF ↗ |
| K864151 | 280SL IMAGING SYSTEM TRANVAGINAL PROBES | Ge Medical Systems Information Technologies | 1987-03-27 | Traditional | PDF ↗ |
| K861371 | TRANSVAGINAL PROBE, MODEL ED65M-TV | Elscint, Inc. | 1986-07-14 | Traditional | PDF ↗ |
| K862072 | FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01 | International Biomedics, Inc. | 1986-07-09 | Traditional | PDF ↗ |
| K861577 | ACUSON S228, S519 & L558 TRANSDUCERS | Acuson Computed Sonography | 1986-06-19 | Traditional | PDF ↗ |
| K861578 | ACUSON S328, L382, L538 & L312 TRANSDUCERS | Acuson Computed Sonography | 1986-06-17 | Traditional | PDF ↗ |
| K860234 | TRANSVAGINAL TRANSDUCER, 5MHZ | Philips Medical Systems, Inc. | 1986-05-23 | Traditional | PDF ↗ |
| K860621 | 1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507 | Impex Medical Systems, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K860313 | 3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031 | Johnson & Johnson Professionals, Inc. | 1986-03-17 | Traditional | PDF ↗ |
| K827885 | BIO-DERM COUPLING LOTION | Whs Products, Inc. | 1982-01-29 | Traditional | PDF ↗ |
| K771869 | DIAG. ULTRASOUND B-SCANNER | Accusonics, Inc. | 1977-11-02 | Traditional | PDF ↗ |
| K771151 | ARTIUS SYSTEM | General Electric Co. | 1977-08-04 | Traditional | PDF ↗ |
Product code HGL · Class II · Obstetrics/Gynecology. Data: openFDA.