Electrocautery, Gynecologic (and Accessories)

Product Code: HGI

Obstetrics/Gynecology Microwave Medical Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 884.4120


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as HGI

3950Electrocautery, Gynecologic (and Accessories)Gynecologic Electrocautery And Accessories.

Total Product Life Cycle (TPLC) Devices

3950Electrocautery, Gynecologic (and Accessories)Gynecologic Electrocautery And Accessories.

Pre-market Notifications for HGI

K202915IRIS Thermocoagulator And Digital ColposcopeLiger Medical, LLC
K152843Liger Medical HTU-110LIGER MEDICAL, LLC
K130606FMWAND FERROMAGNETIC SURGICAL SYSTEMDOMAIN SURGICAL, INC.
K121881DOMAIN SURGICAL SYSTEMDOMAIN SURGICAL, INC.
K070877ENDOCERVICAL ELECTRODE # 2MODERN MEDICAL EQUIPMENT MFG., LTD.
K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158APPLE MEDICAL CORP.
K022593THOMAS MEDICAL ELECTRODESTHOMAS MEDICAL, INC.
K003608SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGYAESCULAP, INC.
K002042TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018NEW ENGLAND MEDICAL CORP.
K993777DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODESR-GROUP INTL.
K993527LOOP ELECTRODE, BALL ELECTRODEPALM MEDICAL USA, INC.
K983840WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)WALLACH SURGICAL DEVICES, INC.
K982739GYNEX ELECTRODESGYNEX CORP.
K974138ROCKET ELECTRODEA & A MEDICAL, INC.
K971986VALLEY FORGE BIPOLAR LOOPVALLEY FORGE SCIENTIFIC CORP.

Global Unique Device Identification Database

00304040007266ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
00304040007242ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
10607151056558Electrocautery, Gynecologic (And Accessories)
10607151056541Electrocautery, Gynecologic (And Accessories)
10607151056534Electrocautery, Gynecologic (And Accessories)
10607151056527Electrocautery, Gynecologic (And Accessories)
10607151056510Electrocautery, Gynecologic (And Accessories)
10607151056503Electrocautery, Gynecologic (And Accessories)
10607151056497Electrocautery, Gynecologic (And Accessories)
10607151056480Electrocautery, Gynecologic (And Accessories)
10607151056473Electrocautery, Gynecologic (And Accessories)
10607151056466Electrocautery, Gynecologic (And Accessories)
10607151056459Electrocautery, Gynecologic (And Accessories)
10607151056442Electrocautery, Gynecologic (And Accessories)
10607151056435Electrocautery, Gynecologic (And Accessories)

Maude Adverse Events

LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2020-03-16
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2020-03-16
LEEP SYSTEM 1000 - 110VCOOPERSURGICAL, INC.2020-03-11
LEEP SYSTEM 1000 ESU GEN.COOPERSURGICAL, INC.2020-03-11
FISCHER CONE BIOP EX SMCOOPERSURGICAL, INC.2020-03-09
LEEP SYSTEM 1000 ESU GEN.COOPERSURGICAL, INC.2020-03-09
LEEP SYSTEM 1000 ESU GEN.COOPERSURGICAL, INC.2020-02-28
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2020-02-28
LEEP SYSTEM 1000 ESU GEN.COOPERSURGICAL, INC.2020-02-28
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2020-02-28
LEEP SYSTEM 1000 ESU GEN.COOPERSURGICAL, INC.2020-02-28
LEEP SYSTEM 1000 ESU GEN.COOPERSURGICAL, INC.2020-02-28
FISCHER CONE BIOP EX MEDCOOPERSURGICAL, INC.2020-02-28
FISCHER CONE BIOP EX M/EXCOOPERSURGICAL, INC.2020-02-28
LEEP SYSTEM 1000 ESU GEN.COOPERSURGICAL, INC.2020-02-26
LEEP PRECISION INTG. SYS.COOPERSURGICAL, INC.2020-02-21
FISCHER CONE BIOP EX MEDCOOPERSURGICAL, INC.2020-02-20
LEEP PRECISION INTG. SYS.COOPERSURGICAL, INC.2020-02-20
QUANTUM2000 ELECTROSURG.COOPERSURGICAL, INC.2020-02-13
FISCHER CONE BIOP EX MEDCOOPERSURGICAL, INC.2020-02-10
100 VOLT LEEP 1000 GENERACOOPERSURGICAL, INC.2020-02-06
LEEP SYSTEM 1000 - 110VCOOPERSURGICAL, INC.2020-02-05
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2020-02-05
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2020-02-05
LEEP SYSTEM 1000 ESU GEN.COOPERSURGICAL, INC.2020-02-04
LEEP SYSTEM 1000 ESU GEN.COOPERSURGICAL, INC.2020-01-15
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2020-01-15
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2020-01-15
JAW INS.BIP.MARYLAND DISS.FEN.5/310MMAESCULAP AG2020-01-08
ETHICON ENSEAL LARGE JAW TISSUE SEALERETHICON ENDO-SURGERY, INC.2019-11-19
JAW INS.BIP.MARYLAND DISS.FEN.5/310MMAESCULAP AG2019-11-14
DISP. IMA/ENT 3/4 NEEDLE ELECTRODETELEFLEX MEDICAL2019-11-11
LEEP SYSTEM 1000 ESU GEN.COOPERSURGICAL, INC.2019-10-18
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2019-10-16
ENSEAL X1ETHICON ENDO-SURGERY, LLC2019-10-09
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2019-10-07
ENSEALETHICON ENDO-SURGERY, LLC2019-10-03
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2019-09-25
MEDLINE RESISTICK?BOVIE MEDICAL CORPORATION2019-09-25
LEEP PRECISION INTG. SYS.COOPERSURGICAL, INC.2019-09-24
LEEP PRECISION INTG. SYS.COOPERSURGICAL, INC.2019-09-24
LEEP PRECISION INTG. SYS.COOPERSURGICAL, INC.2019-09-23
FISCHER CONE BIOP EX SMCOOPERSURGICAL, INC.2019-09-23
FISCHER CONE BIOP EX LGCOOPERSURGICAL, INC.2019-09-10
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2019-09-05
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2019-09-04
LEEP SYSTEM 1000 ESU GEN.COOPERSURGICAL, INC.2019-09-04
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2019-08-30
LEEP PRECISION GENERATORCOOPERSURGICAL, INC.2019-08-30
QUANTUM2000 ELECTROSURG.COOPERSURGICAL, INC.2019-08-26

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