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HQR — Apparatus, Cautery, Radiofrequency, Ac-Powered Class II

FDA Device Classification

Classification Details

Product Code
HQR
Device Class
Class II
Regulation Number
886.4100
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K050308starion instrumentsTHERMAL CAUTERY PROBEFebruary 25, 2005
K990064ophthalmic technologiesDI-RHEX OPHTHALMIC DIATHERMY SYSTEMApril 4, 1999
K980522refractecREFRACTEC MCS-100July 22, 1998
K972749c.m. chancePAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)March 13, 1998
K952151storzSTORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CMarch 4, 1996
K955158ellman intlSURGITRONFebruary 9, 1996
K952569gamp and assocGAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATORJanuary 5, 1996
K941495miraRETURN PATH DIATHERMY HANDLEJuly 15, 1994
K934320mentor o and oMENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION AFebruary 16, 1994
K895800advanced surgical productsADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATORJanuary 22, 1990
K870194united surgicalUNITED SURGICAL CORP. DIATHERMIC PLUSFebruary 20, 1987