SMARTSTITCH PERFECTPASSER SYSTEM

Suture, Nonabsorbable, Synthetic, Polyethylene

ARTHOCARE CORPORATION

The following data is part of a premarket notification filed by Arthocare Corporation with the FDA for Smartstitch Perfectpasser System.

Pre-market Notification Details

Device IDK123268
510k NumberK123268
Device Name:SMARTSTITCH PERFECTPASSER SYSTEM
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant ARTHOCARE CORPORATION 7000 West William Cannon Drive Austin,  TX  78735
ContactCheryl Frederick
CorrespondentCheryl Frederick
ARTHOCARE CORPORATION 7000 West William Cannon Drive Austin,  TX  78735
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-19
Decision Date2012-11-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817470007442 K123268 000
20817470001116 K123268 000
00817470001679 K123268 000
00817470005714 K123268 000
20817470005800 K123268 000
00817470005813 K123268 000
20817470005824 K123268 000
00817470005837 K123268 000
00817470005844 K123268 000
00817470005912 K123268 000
00817470006971 K123268 000
00817470007381 K123268 000
20817470007392 K123268 000
00817470007404 K123268 000
20817470007415 K123268 000
00817470007428 K123268 000
20817470007439 K123268 000
00817470001105 K123268 000

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