ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)

Laparoscope, General & Plastic Surgery

ETHICON ENDO-SURGERY, INC.

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Endoscopic Tissue Fastening System (etfs).

Pre-market Notification Details

Device IDK980022
510k NumberK980022
Device Name:ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
ClassificationLaparoscope, General & Plastic Surgery
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
ContactLorri Chavez
CorrespondentLorri Chavez
ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-05
Decision Date1998-03-09
Summary:summary

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