Product code HGL— Obstetrics/Gynecology
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
- Classification name
- Transducer, Ultrasonic, Obstetric
- Device class
- Class 2
- Regulation
- 21 CFR 884.2960
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 36
- First cleared
- Most recent
Market context for product code HGL
FDA has cleared devices under product code HGL between 1977 and 1995, filed by 25 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1995
- 1994
- 1993
- 1990
- 1989
- 1988
- 1987
- 1986
- 1982
- 1977
Top applicants under product code HGL
Recent clearances under product code HGL
- K952031 — ULTRASOUND TRANSDUCER, MODEL US917
- K923335 — ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION
- K924516 — OP3/VP4
- K903348 — ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
- K900966 — EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
- K901142 — MER MULTIPLANE VAGINAL PROBE (MVP)
- K903316 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
- K900838 — TRANSVAGINAL TRANSDUCER ASSEMBLY
- K895449 — ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
- K881263 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
- K895647 — 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
- K895123 — 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
- K895026 — HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
- K894415 — DYMAX ENDOVAGINAL BIOPSY GUIDE
- K892070 — GENERAL IVT NEEDLE GUIDE KIT, STERILE
- K881405 — SIEMENS INTRAVAGINAL TRANSDUCER
- K875334 — KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
- K875371 — KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
- K872265 — ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.
- K871856 — ANNULAR ARRAY SCANHEAD
- K863797 — BIOPSY NEEDLE GUIDE ATTACHMENT
- K864151 — 280SL IMAGING SYSTEM TRANVAGINAL PROBES
- K864219 — TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE
- K864578 — ACUSON TV519 TRANSDUCER
- K864908 — DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE
- K870709 — 7.5 MHZ ENDOVAGINAL PROBE
- K861371 — TRANSVAGINAL PROBE, MODEL ED65M-TV
- K862072 — FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01
- K861577 — ACUSON S228, S519 & L558 TRANSDUCERS
- K861578 — ACUSON S328, L382, L538 & L312 TRANSDUCERS
- K860234 — TRANSVAGINAL TRANSDUCER, 5MHZ
- K860621 — 1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507
- K860313 — 3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031
- K827885 — BIO-DERM COUPLING LOTION
- K771869 — DIAG. ULTRASOUND B-SCANNER
- K771151 — ARTIUS SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.