PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS

Staple, Implantable

ETHICON ENDO-SURGERY, INC.

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Proximate Curved And Straight Intraluminal Staplers.

Pre-market Notification Details

Device IDK983536
510k NumberK983536
Device Name:PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS
ClassificationStaple, Implantable
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
ContactEdwin O Billips
CorrespondentEdwin O Billips
ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-09
Decision Date1998-12-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30705036014069 K983536 000
10705036003458 K983536 000
10705036003465 K983536 000
10705036003472 K983536 000
10705036003519 K983536 000
10705036003526 K983536 000
10705036003533 K983536 000
10705036003540 K983536 000
20705036003448 K983536 000
20705036003455 K983536 000
20705036003462 K983536 000
20705036003479 K983536 000
20705036003516 K983536 000
20705036003523 K983536 000
20705036003530 K983536 000
20705036003547 K983536 000
30705036014052 K983536 000
10705036003441 K983536 000

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