STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

Stryker Endoscopy

The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Wireless Universal Footswitch System.

Pre-market Notification Details

Device IDK033135
510k NumberK033135
Device Name:STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant Stryker Endoscopy 5900 OPTICAL CT. San Jose,  CA  95138
ContactMike Hilldoerfer
CorrespondentMike Hilldoerfer
Stryker Endoscopy 5900 OPTICAL CT. San Jose,  CA  95138
Product CodeKNS  
Subsequent Product CodeGCJ
Subsequent Product CodeHRX
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-30
Decision Date2004-08-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327060942 K033135 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.