FDA.reportPublic FDA data

VORTEK SURGICAL, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30063652493006365249VORTEK SURGICAL, LLC1N2020-04-257626 East 88th Place Indianapolis IN US 46256

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B27810689076068659ENDODRAPE® - "ENDODRAPE® Colonoscopy, 49"" x 52"""3173483555sales@vorteksurgical.com
B27810689076069052ENDODRAPE® - "ENDODRAPE® Upper Endoscopy, 38"" x 54"""3173483555sales@vorteksurgical.com
B27820689076068659ENDODRAPE® - ENDODRAPE® Colonoscopy, 49" x 52"3173483555sales@vorteksurgical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1123601584607703K080341ENDODRAPE(TM)KKX2008-07-21
1123601790630255K070406ENDODRAPEKKX2007-07-30
1123601278069371

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KKX22008-07-21

PMN#

GUDID#