FDA product code HGI: Electrocautery, Gynecologic (And Accessories)
HGI is the FDA product code for electrocautery, gynecologic (and accessories). It is a Class II device, regulated under 21 CFR 884.4120 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 53 510(k) submissions under HGI, from 36 different applicants. The average 510(k) review took 297 days (median 239). FDA has posted 24 recalls for HGI devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrocautery, Gynecologic (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.4120 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HGI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 206 |
Compare with all 510(k) review times · Search every HGI clearance
Top HGI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wallach Surgical Devices, Inc. | 5 | 1999-05-20 |
| Utah Medical Products, Inc. | 4 | 1997-07-03 |
| Valleylab, Inc. | 3 | 1993-09-07 |
| Liger Medical, LLC | 2 | 2021-04-23 |
| Domain Surgical, Inc. | 2 | 2014-01-03 |
31 more applicants have HGI clearances. See the full list in Caduvo.
Most recent HGI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202915 | Liger Medical, LLC | IRIS Thermocoagulator and Digital Colposcope | 2021-04-23 | 206 |
| K152843 | Liger Medical, LLC | Liger Medical HTU-110 | 2016-06-24 | 269 |
| K130606 | Domain Surgical, Inc. | FMWAND FERROMAGNETIC SURGICAL SYSTEM | 2014-01-03 | 302 |
| K121881 | Domain Surgical, Inc. | DOMAIN SURGICAL SYSTEM | 2012-10-18 | 114 |
| K070877 | Modern Medical Equipment Mfg., Ltd. | ENDOCERVICAL ELECTRODE # 2 | 2007-07-27 | 120 |
Recalls for HGI devices
24 product recalls in 9 recall events; 1 initiated in the last five years and 8 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 5 |
| 2021 | 7 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code HGI?
HGI is the FDA product code for electrocautery, gynecologic (and accessories). It is a Class II device, regulated under 21 CFR 884.4120 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGI?
Class II, regulation 21 CFR 884.4120. Typical premarket route: 510(k).
How long does a 510(k) take for product code HGI?
Across 53 cleared submissions the average was 297 days from receipt to decision (median 239).
Which companies have the most HGI clearances?
Wallach Surgical Devices, Inc. (5); Utah Medical Products, Inc. (4); Valleylab, Inc. (3); Liger Medical, LLC (2); Domain Surgical, Inc. (2).
Have HGI devices been recalled?
Yes: 24 product recalls across 9 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code HGI
- Run a recall and safety report across every HGI manufacturer
- Watch product code HGI 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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