FDA.reportPublic FDA data

SUTURE CONCEPTS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121015263012101526SUTURE CONCEPTS1N2020-04-25100 Cummings Ctr Ste 348C Beverly MA US 01915

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
M759CATTFD01Lead Loop - Suture Concepts Trail Lead Fixation Device9789690070orders@sutureconcepts.com
M759LLSD10Lead Loop - Suture Concepts Lead Loop Suturing Device9789690070orders@sutureconcepts.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1869512013531222K150924A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter DeviceGZB2015-07-27
1869511118987927

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GZB12015-07-27

GUDID#