SPY Laparoscope

Laparoscope, General & Plastic Surgery

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Spy Laparoscope.

Pre-market Notification Details

Device IDK221217
510k NumberK221217
Device Name:SPY Laparoscope
ClassificationLaparoscope, General & Plastic Surgery
Applicant Stryker 5900 Optical Court San Jose,  CA  95138
ContactChristie Samsa
CorrespondentChristie Samsa
Stryker 5900 Optical Court San Jose,  CA  95138
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-27
Decision Date2022-06-17

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