KARL STORZ SUCTION/IRRIGATION TUBES. CANNULAE, SHEATHS

Laparoscope, General & Plastic Surgery

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Suction/irrigation Tubes. Cannulae, Sheaths.

Pre-market Notification Details

Device IDK945059
510k NumberK945059
Device Name:KARL STORZ SUCTION/IRRIGATION TUBES. CANNULAE, SHEATHS
ClassificationLaparoscope, General & Plastic Surgery
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactBetty M Johnson
CorrespondentBetty M Johnson
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-14
Decision Date1994-11-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551365328 K945059 000
04048551155516 K945059 000
04048551155509 K945059 000
04048551155462 K945059 000
04048551155394 K945059 000
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04048551290859 K945059 000
04048551084748 K945059 000
04048551086841 K945059 000
04048551101322 K945059 000
04048551290873 K945059 000
04048551155585 K945059 000
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04048551155615 K945059 000
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04048551155844 K945059 000
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04048551155813 K945059 000
04048551155738 K945059 000
04048551155721 K945059 000
04048551155622 K945059 000
04048551256473 K945059 000

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