ELECTROCAUTERY SHROUD

Laparoscope, General & Plastic Surgery

I.C. MEDICAL, INC.

The following data is part of a premarket notification filed by I.c. Medical, Inc. with the FDA for Electrocautery Shroud.

Pre-market Notification Details

Device IDK953418
510k NumberK953418
Device Name:ELECTROCAUTERY SHROUD
ClassificationLaparoscope, General & Plastic Surgery
Applicant I.C. MEDICAL, INC. 5170 PHELPS RD. SUITE D Glendale,  AZ  85306
ContactKurt Hasper
CorrespondentKurt Hasper
I.C. MEDICAL, INC. 5170 PHELPS RD. SUITE D Glendale,  AZ  85306
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-14
Decision Date1995-10-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817688022404 K953418 000
00817688021087 K953418 000
00817688021100 K953418 000
00817688021124 K953418 000
00817688021162 K953418 000
00817688021186 K953418 000
00817688021209 K953418 000
00817688021223 K953418 000
00817688021247 K953418 000
00817688021933 K953418 000
00817688021940 K953418 000
00817688021971 K953418 000
00817688021988 K953418 000
00817688021995 K953418 000
00817688022268 K953418 000
00817688022299 K953418 000
00817688021063 K953418 000

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