Home › Device types › HGI
Electrocautery, Gynecologic (And Accessories)
FDA product code HGI · Class 2 · Obstetrics/Gynecology
519
Registered devices
780
Adverse events
24
Recalls
53
510(k) clearances
Devices with this code
DeRoyal — DEROYAL INDUSTRIES, INC.CONMED — Conmed CorporationBovie — ASPEN SURGICAL PRODUCTS, INC.OptiMicro — UTAH MEDICAL PRODUCTS, INC.Radius Loop Electrodes — GYNEX CORPORATIONBovie — ASPEN SURGICAL PRODUCTS, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.Bovie — ASPEN SURGICAL PRODUCTS, INC.Carrera Loop Electrodes — GYNEX CORPORATIONCarrera Loop Electrodes — GYNEX CORPORATIONAESCULAP — Aesculap AGLEEP System 1000® Generator — Coopersurgical, Inc.Bovie — ASPEN SURGICAL PRODUCTS, INC.NA — C R IBovie — ASPEN SURGICAL PRODUCTS, INC.Bovie — ASPEN SURGICAL PRODUCTS, INC.Henry Schein — HENRY SCHEIN, INC.Bovie — ASPEN SURGICAL PRODUCTS, INC.Gynex — GYNEX CORPORATIONDeRoyal — DEROYAL INDUSTRIES, INC.AESCULAP — Aesculap AGGreenwald Surgical Device Company, Inc. — GRACE MANUFACTURING, INC.Bovie — ASPEN SURGICAL PRODUCTS, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.
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. | 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 |
| 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 |
| 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 |
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