Aesculap Caiman 12 Seal And Cut Technology System

Electrosurgical, Cutting & Coagulation & Accessories

Aesculap Inc.

The following data is part of a premarket notification filed by Aesculap Inc. with the FDA for Aesculap Caiman 12 Seal And Cut Technology System.

Pre-market Notification Details

Device IDK203461
510k NumberK203461
Device Name:Aesculap Caiman 12 Seal And Cut Technology System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Aesculap Inc. 3773 Corporate Parkway Center Valley,  PA  18034
ContactOmunique Luke
CorrespondentOmunique Luke
Aesculap Inc. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-24
Decision Date2020-12-18

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.