INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321

Ligator, Esophageal

ETHICON ENDO-SURGERY, INC.

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Inscope Multi-clip Applier, Models In22321, In23321.

Pre-market Notification Details

Device IDK051950
510k NumberK051950
Device Name:INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321
ClassificationLigator, Esophageal
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
ContactKimberly Shoemaker
CorrespondentKimberly Shoemaker
ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
Product CodeMND  
Subsequent Product CodeFHN
Subsequent Product CodeHBT
Subsequent Product CodeMCH
Subsequent Product CodeOCW
CFR Regulation Number876.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-18
Decision Date2005-10-07
Summary:summary

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