Saberscope5 Laparoscope

Laparoscope, General & Plastic Surgery

Xenocor, Inc

The following data is part of a premarket notification filed by Xenocor, Inc with the FDA for Saberscope5 Laparoscope.

Pre-market Notification Details

Device IDK220872
510k NumberK220872
Device Name:Saberscope5 Laparoscope
ClassificationLaparoscope, General & Plastic Surgery
Applicant Xenocor, Inc 350 E. 400 S., Suite 401 Salt Lake City,  UT  84111
ContactEvan Kelso
CorrespondentSpencer Walker
Peak Regulatory Consulting, LLC 370 S. 300 E. Salt Lake City,  UT  84111
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-25
Decision Date2022-04-20

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