ECHELON GRAY CARTRIDGE, MODEL ERC45M

Staple, Implantable

ETHICON ENDO-SURGERY, LLC

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Echelon Gray Cartridge, Model Erc45m.

Pre-market Notification Details

Device IDK080839
510k NumberK080839
Device Name:ECHELON GRAY CARTRIDGE, MODEL ERC45M
ClassificationStaple, Implantable
Applicant ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati,  OH  45242
ContactRuth Ann Wood
CorrespondentRuth Ann Wood
ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati,  OH  45242
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-25
Decision Date2008-05-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30705036013796 K080839 000
30705036001755 K080839 000

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