SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE

Endoscopic Tissue Approximation Device

SURGICAL INNOVATIONS CORP.

The following data is part of a premarket notification filed by Surgical Innovations Corp. with the FDA for Surgical Innovations Disposable Endoscopic Hernia Surgical Stapler Surgical Innovations Resuable Surgical Stapler Handle.

Pre-market Notification Details

Device IDK944292
510k NumberK944292
Device Name:SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE
ClassificationEndoscopic Tissue Approximation Device
Applicant SURGICAL INNOVATIONS CORP. 6 PHEASANT LN. Claremont,  NH  03743
ContactMichele Motsiff
CorrespondentMichele Motsiff
SURGICAL INNOVATIONS CORP. 6 PHEASANT LN. Claremont,  NH  03743
Product CodeOCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-02
Decision Date1994-11-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.