FDA product code HGL: Transducer, Ultrasonic, Obstetric
HGL is the FDA product code for transducer, ultrasonic, obstetric. It is a Class II device, regulated under 21 CFR 884.2960 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 36 510(k) submissions under HGL, from 25 different applicants. The average 510(k) review took 140 days (median 92). 1 PMA application cites this product code. FDA has posted 4 recalls for HGL devices.
Classification
| Field | Value |
|---|---|
| Device name | Transducer, Ultrasonic, Obstetric |
| Device class | Class II |
| Regulation | 21 CFR 884.2960 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HGL clearance
Top HGL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Technology Laboratories, Inc. | 4 | 1990-10-22 |
| Ge Medical Systems Information Technologies | 3 | 1990-08-22 |
| Acuson Computed Sonography | 3 | 1987-03-27 |
| Advanced Medical Systems, Inc. | 2 | 1995-07-18 |
| Amedic USA | 2 | 1989-09-05 |
20 more applicants have HGL clearances. See the full list in Caduvo.
Most recent HGL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952031 | Advanced Medical Systems, Inc. | ULTRASOUND TRANSDUCER, MODEL US917 | 1995-07-18 | 78 |
| K923335 | Advanced Medical Systems, Inc. | ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION | 1994-07-22 | 774 |
| K924516 | Huntleigh Technology, Inc. | OP3/VP4 | 1993-06-28 | 297 |
| K903348 | Advanced Technology Laboratories, Inc. | ULTRASONIC PULSED DOPPLER IMAGING SYSTEM | 1990-10-22 | 88 |
| K900966 | Hitachi Medical Corp. of America | EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE | 1990-09-12 | 195 |
Recalls for HGL devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 4 still open. Most recent: 2019-09-11.
| Year | Recalls |
|---|---|
| 2019 | 4 |
Frequently asked questions
What is FDA product code HGL?
HGL is the FDA product code for transducer, ultrasonic, obstetric. It is a Class II device, regulated under 21 CFR 884.2960 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGL?
Class II, regulation 21 CFR 884.2960. Typical premarket route: 510(k).
How long does a 510(k) take for product code HGL?
Across 36 cleared submissions the average was 140 days from receipt to decision (median 92).
Which companies have the most HGL clearances?
Advanced Technology Laboratories, Inc. (4); Ge Medical Systems Information Technologies (3); Acuson Computed Sonography (3); Advanced Medical Systems, Inc. (2); Amedic USA (2).
Have HGL devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2019-09-11.
Next steps
- Run an FDA pathway report with predicate devices for product code HGL
- Run a recall and safety report across every HGL manufacturer
- Watch product code HGL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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