PRE-TIED LOOP SUTURE CANNULA

Laparoscope, General & Plastic Surgery

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Pre-tied Loop Suture Cannula.

Pre-market Notification Details

Device IDK925914
510k NumberK925914
Device Name:PRE-TIED LOOP SUTURE CANNULA
ClassificationLaparoscope, General & Plastic Surgery
Applicant ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville,  NJ  08876 -0151
ContactJohn D Paulson
CorrespondentJohn D Paulson
ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville,  NJ  08876 -0151
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-23
Decision Date1993-05-12

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