Apparatus, Cautery, Radiofrequency, Ac-powered

Product Code: HQR

Ophthalmic 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: 886.4100


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as HQR

4305Apparatus, Cautery, Radiofrequency, Ac-poweredRadiofrequency Electrosurgical Cautery Apparatus.

Total Product Life Cycle (TPLC) Devices

4305Apparatus, Cautery, Radiofrequency, Ac-poweredRadiofrequency Electrosurgical Cautery Apparatus.

Pre-market Notifications for HQR

K050308THERMAL CAUTERY PROBESTARION INSTRUMENTS
K990064DI-RHEX OPHTHALMIC DIATHERMY SYSTEMOPHTHALMIC TECHNOLOGIES, INC.
K980522REFRACTEC MCS-100REFRACTEC, INC.
K955158SURGITRONELLMAN INTL., INC.
K952569GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATORGAMP & ASSOC.
K952151STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)STORZ
K941495RETURN PATH DIATHERMY HANDLEMIRA, INC.
K934320MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATIONMENTOR O & O, INC.
K895800ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATORADVANCED SURGICAL PRODUCTS, INC.
K870194UNITED SURGICAL CORP. DIATHERMIC PLUSUNITED SURGICAL CORP.

Global Unique Device Identification Database

10380651295015Apparatus, cautery, radiofrequency, ac-powered
10380651293011Apparatus, cautery, radiofrequency, ac-powered
10380651291017Apparatus, cautery, radiofrequency, ac-powered
00380651284029Apparatus, cautery, radiofrequency, ac-powered
00380651282018Apparatus, cautery, radiofrequency, ac-powered
00380651280014Apparatus, cautery, radiofrequency, ac-powered
00380651275010Apparatus, cautery, radiofrequency, ac-powered
00854028002092Apparatus, Cautery, Radiofrequency, Ac-Powered
20841305111053Apparatus, cautery, radiofrequency, ac-powered
20841305108039APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED
20841305108022APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED
20841305108015APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED
08717872000480Apparatus, Cautery, Radiofrequency, Ac-Powered
08717872000381Apparatus, Cautery, Radiofrequency, Ac-Powered
08717872000411Apparatus, Cautery, Radiofrequency, Ac-Powered

Maude Adverse Events

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INTREPID AUTOSERT IOL HANDPIECEALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER2015-11-24
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INTREPID AUTOSERT IOL HANDPIECEALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER2015-05-26
DIATHERMY HANDPIECEMIRA INC.2014-01-10
POLYMER I/A TIP, DISPOSABLEALCON PRECISION DEVICE - SINKING SPRING2013-09-24
CAUTERY FORCEPSSTARION INSTRUMENTS2011-05-13
EXHALENTSTARION INSTRUMENTS2011-03-30
EXHALENTSTARION INSTRUMENTS2011-03-30
EXHALENTSTARION INSTRUMENTS2011-03-30
WET-FIELD HEMOSTATIC ERASERMEDTRONIC OPHTHALMICS2011-03-22
MIRA OS4081 TRANSILLUMINATING DIATHERMY HANDLEMIRA, INC.2010-06-17
SURGITRONELLMAN INT'L INC.2008-10-21
*VIEWPOINT CK SYSTEMREFRACT2006-04-18
REFRACTECUNK2004-11-30
STORZ REUSABLE ERASERSTORZ INSTRUMENT GMBH1997-07-16
OPHTHALMIC DIATHERMYMIRA, INC.1995-02-27
KARL STORZKARL STORZ ENDOSCOPY/AMERICA, INC.1994-07-29
FORCE 2 CAUTERYVALLEYLAB1993-01-29
N/AHIGH TEMP CAUTERYXOMED - TREACE1992-07-21
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