SPINEWAND SURGICAL DEVICE

Electrosurgical, Cutting & Coagulation & Accessories

ARTHROCARE CORP.

The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Spinewand Surgical Device.

Pre-market Notification Details

Device IDK100353
510k NumberK100353
Device Name:SPINEWAND SURGICAL DEVICE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale,  CA  94085 -3523
ContactValerie Defiesta-ng
CorrespondentValerie Defiesta-ng
ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale,  CA  94085 -3523
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-12
Decision Date2010-05-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817470007503 K100353 000
00817470007497 K100353 000
00817470007480 K100353 000

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