Creo Electrosurgical System With HS1 Hemostasis 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 Electrosurgical System With Hs1 Hemostasis Accessory.

Pre-market Notification Details

Device IDK192905
510k NumberK192905
Device Name:Creo Electrosurgical System With HS1 Hemostasis Accessory
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant Creo Medical Ltd. Creo House, Unit 2, Beaufort Park Way Chepstow,  GB Np16 5uh
ContactLeif Geoghegan
CorrespondentLeif Geoghegan
Phil Triolo And Associates LC 86 Skycrest Ln Salt Lake City,  UT  84108
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-15
Decision Date2020-03-19

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