11

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 11.

Pre-market Notification Details

Device IDK222504
510k NumberK222504
Device Name:11
ClassificationLaparoscope, General & Plastic Surgery
Applicant Karl Storz Endoscopy America, Inc. 2151 E. Grand Avenue El Segundo,  CA  90245
ContactMario Trujillo
CorrespondentWinkie Wong
Karl Storz Endoscopy America, Inc. 2151 E. Grand Avenue El Segundo,  CA  90245
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-18
Decision Date2022-11-10

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