Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1812606600
Device Listing 1812606600
Listing Summary
#
Listing key
1812606600
Premarket submission
K170548
Device
InSure ONE
Applicant
Enterix, Inc.
Product code
KHE
Decision date
2017-10-05
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
58004
1226769
3003224146
ENTERIX INC.
1
N
2020-04-25
236 Fernwood Ave EDISON NJ US 08837
58005
3005311019
3005311019
Erica Franco
1
N
2026-01-01
236 Fernwood Ave Edison NJ US 08837