Home › Device types › HGI
Electrocautery, Gynecologic (And Accessories)
FDA product code HGI · Class 2 · Obstetrics/Gynecology
506
Registered devices
777
Adverse events
24
Recalls
53
510(k) clearances
Devices with this code
Carrera Loop Electrodes — GYNEX CORPORATIONRadius Loop Electrodes — GYNEX CORPORATIONLEEP Radius Electrode — Coopersurgical, Inc.WECK — TELEFLEX INCORPORATEDLEEP System 1000® Generator — Coopersurgical, Inc.Olympus — Modern Medical Equipment MFG. Ltd.AESCULAP — Aesculap AGCarrera Ball Electrodes — GYNEX CORPORATIONBovie — ASPEN SURGICAL PRODUCTS, INC.Greenwald Surgical Device Company, Inc. — GRACE MANUFACTURING, INC.DXTender — UTAH MEDICAL PRODUCTS, INC.Bovie — ASPEN SURGICAL PRODUCTS, INC.FINESSE — UTAH MEDICAL PRODUCTS, INC.Carrera Loop Electrode — GYNEX CORPORATIONAESCULAP — Aesculap AGPremier — PREMIER DENTAL PRODUCTS COMPANYArgent — MCKESSON MEDICAL-SURGICAL INC.N/A — UTAH MEDICAL PRODUCTS, INC.Bovie — ASPEN SURGICAL PRODUCTS, INC.Gynex — GYNEX CORPORATIONBOVIE — ASPEN SURGICAL PRODUCTS, INC.Fischer Cone — Coopersurgical, Inc.Radius Loop Electrodes — GYNEX CORPORATIONWECK — TELEFLEX INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2021-09-29 | CooperSurgical, Inc. | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medica |
| 2021-09-29 | CooperSurgical, Inc. | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medica |
| 2021-09-29 | CooperSurgical, Inc. | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medica |
| 2021-09-29 | CooperSurgical, Inc. | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medica |
| 2021-09-29 | CooperSurgical, Inc. | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medica |
| 2021-09-29 | CooperSurgical, Inc. | XXX |
| 2021-09-29 | CooperSurgical, Inc. | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medica |
| 2019-10-16 | CooperSurgical, Inc. | Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a pro |
| 2019-10-16 | CooperSurgical, Inc. | Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a pro |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.