Bolder Surgical, LLC

Louisville, CO, US

BOLDER SURGICAL, LLC appears in FDA device records in Louisville, CO. FDA records list 8 510(k) clearances between 2013-05-22 and 2023-11-15, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 5 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 8
PMA records: 0
Recall records: 5
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Bolder Surgical, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Justright Surgical, LLC510(k), enforcement report, recall

510(k) clearance history

FDA records hold 8 510(k) clearances for Bolder Surgical, LLC between 2013 and 2023. The busiest year on record is 2021, with 3. The most recent is 2023, with 1.

Clearances by year, as a table

510(k) clearance decisions for Bolder Surgical, LLC, by decision year
Year	Clearances
2013	1
2014	1
2016	1
2020	1
2021	3
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K231012	CoolSeal Trinity	GEI	Substantially Equivalent	2023-11-15
K211579	CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)	GEI	Substantially Equivalent	2021-09-07
K203640	CoolSeal Reveal	GEI	Substantially Equivalent	2021-05-06
K203183	CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)	GEI	Substantially Equivalent	2021-05-06
K202114	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	GEI	Substantially Equivalent	2020-10-06
K160602	JustRight Surgical Vessel Sealing System	GEI	Substantially Equivalent	2016-06-23
K132472	JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD	GDW	Substantially Equivalent	2014-02-11
K123662	THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM	GEI	Substantially Equivalent	2013-05-22

Registered establishments

FDA registered establishments for Bolder Surgical, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3010377594	3010377594	BOLDER SURGICAL, LLC	331 S. 104th Street, LOUISVILLE, CO 80027 US	2026	GAG GDW GEI

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0736-2022	CoolSeal Generator, REF: CSL-200-50	A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of unintended energy to the patient.	Class II	2022-01-25	Terminated
Z-1956-2015	JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and creation of anastomosis.	JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue closure.	Class II	2015-06-11	Terminated
Z-1955-2015	JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and creation of anastomosis.	JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue closure.	Class II	2015-06-11	Terminated
Z-2691-2014	Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery.	JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.	Class II	2014-08-27	Terminated
Z-2690-2014	Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis.	JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.	Class II	2014-08-27	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain