ENDOBUTTON DIRECT

Fastener, Fixation, Nondegradable, Soft Tissue

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Division with the FDA for Endobutton Direct.

Pre-market Notification Details

Device IDK070167
510k NumberK070167
Device Name:ENDOBUTTON DIRECT
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant SMITH & NEPHEW INC., ENDOSCOPY DIVISION 150 MINUTEMAN RD. Andover,  MA  01810
ContactDeana Boushell
CorrespondentDeana Boushell
SMITH & NEPHEW INC., ENDOSCOPY DIVISION 150 MINUTEMAN RD. Andover,  MA  01810
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-18
Decision Date2007-04-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885554015041 K070167 000
03596010592361 K070167 000
03596010592026 K070167 000
03596010592019 K070167 000
03596010592002 K070167 000
03596010591999 K070167 000

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