Bolder Surgical L L C

FDA Filings

This page includes the latest FDA filings for Bolder Surgical L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010377594
• FEI Number: 3010377594
• Name: BOLDER SURGICAL, LLC
• Owner & Operator: Bolder Surgical
• Contact Address: 331 South 104th Street Suite 200; Louisville CO 80027 US
• Official Correspondent:
  • Claire C Bronstein
  • 1-720-2877146-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 331 S. 104th Street Suite 200; LOUISVILLE, CO 80027 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K203640 Bolder Surgical, LLC	CoolSeal Reveal	2021-05-06
PMN K203183 Bolder Surgical, LLC	CoolSeal Trinity (30 Cm Shaft, 37 Cm Shaft, And 44 Cm Shaft)	2021-05-06
PMN K202114 Bolder Surgical, LLC	CoolSeal 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-MN103-20	2020-10-06
PMN K160602 | GEI BOLDER SURGICAL, LLC [Bolder Surgical]	JustRight Surgical Vessel Sealing System	2016-09-28
PMN K160602 | GEI BOLDER SURGICAL, LLC [Bolder Surgical]	JustRight Sealer	2016-09-28
PMN K160602 | GEI BOLDER SURGICAL, LLC [Bolder Surgical]	JustRight Generator	2016-09-28
PMN K160602 | GEI BOLDER SURGICAL, LLC [Bolder Surgical]	JustRight 5mm Stapler	2016-09-28
PMN K160602 | GEI BOLDER SURGICAL, LLC [Bolder Surgical]	JustRight 5mm Reload	2016-09-28
PMN K132472 | GDW BOLDER SURGICAL, LLC [Bolder Surgical]	JustRight 5mm Stapler	2014-06-23
PMN K132472 | GDW BOLDER SURGICAL, LLC [Bolder Surgical]	JustRight 5mm Reload	2014-06-23
PMN K132472 | GAG BOLDER SURGICAL, LLC [Bolder Surgical]	JustRight 5mm Stapler	2014-06-23
PMN K132472 | GAG BOLDER SURGICAL, LLC [Bolder Surgical]	JustRight 5mm Reload	2014-06-23
PMN K123662 | GEI BOLDER SURGICAL, LLC [Bolder Surgical]	JustRight Sealer	2013-06-27
PMN K123662 | GEI BOLDER SURGICAL, LLC [Bolder Surgical]	JustRight Generator	2013-06-27

Related Finance Registrations

CAGE Code

7HE47

BOLDER SURGICAL, LLC JUSTRIGHT SURGICAL LLC