Creo Medical Electrosurgical System Including Speedboat RS2 Surgical Accessory

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

Creo Medical Ltd

The following data is part of a premarket notification filed by Creo Medical Ltd with the FDA for Creo Medical Electrosurgical System Including Speedboat Rs2 Surgical Accessory.

Pre-market Notification Details

Device IDK171983
510k NumberK171983
Device Name:Creo Medical Electrosurgical System Including Speedboat RS2 Surgical Accessory
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant Creo Medical Ltd Riverside Court, Beaufort Park Chepstow,  GB Np16 5uh
ContactKeith Penny
CorrespondentKeith Penny
Creo Medical Ltd. Riverside Court, Beaufort Park Chepstow,  GB Np16 5uh
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-30
Decision Date2017-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060359560124 K171983 000
05060359560087 K171983 000
05060359560063 K171983 000
05060359560025 K171983 000
05060359560070 K171983 000
05060359560292 K171983 000
05060359560599 K171983 000
05060359560919 K171983 000

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