FDA.reportPublic FDA data

BOLDER SURGICAL, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103775943010377594BOLDER SURGICAL, LLC1N2026-01-01331 S. 104th Street Suite 200 LOUISVILLE CO US 80027
30103775943010377594BOLDER SURGICAL, LLC1N2020-04-25331 S. 104th Street Suite 200 LOUISVILLE CO US 80027

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3420521259920593K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)GEI2021-09-07
3420522024439993K203640CoolSeal RevealGEI2021-05-06
3420521085255110K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20GEI2020-10-06
1601731858079619K160602JustRight Surgical Vessel Sealing SystemGEI2016-06-23
1601731098753075K132472JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOADGDW2014-02-11
3420521546165177K132472JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOADGDW2014-02-11
1601731415719608K123662THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEMGEI2013-05-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI52021-09-07
GDW22014-02-11

PMN#