Data / Medical devices / United States / Bolder Surgical, LLC
Bolder Surgical, LLC: FDA-registered device maker in Louisville, CO, United States, 4 510(k) clearances
Bolder Surgical, LLC is registered with the FDA (registration 3010377594) in Louisville, CO, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 7, 2021. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010377594
- Address
- 331 S. 104th Street Suite 200, Louisville, CO, United States, 80027
- Owner or operator
- HOLOGIC, INC. (9007676)
- Roles
- Specification developer
- First device listed
- January 4, 2023
- Registered through
- 2026
- Brand names listed
- CoolSeal Mini; CoolSeal Generator, CoolSeal Reveal, CoolSeal Trinity, JustRight 5mm Reload; JustRight 5mm Stapler
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Specification developer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Specification developer | accessdata.fda.gov |
| Stapler, Surgical | GAG | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 7, 2021 | K211579 | CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) | GEI | Substantially Equivalent | Bolder Surgical, LLC | accessdata.fda.gov |
| May 6, 2021 | K203640 | CoolSeal Reveal | GEI | Substantially Equivalent | Bolder Surgical, LLC | accessdata.fda.gov |
| October 6, 2020 | 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 | Bolder Surgical, LLC | accessdata.fda.gov |
| February 11, 2014 | K132472 | JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD | GDW | Substantially Equivalent | Justright Surgical, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 25, 2022 | 89570 | Class II | Terminated | 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. | accessdata.fda.gov |
| June 11, 2015 | 71521 | Class II | Terminated | 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 t | JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue closure. | accessdata.fda.gov |
| August 27, 2014 | 69140 | Class II | Terminated | 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 thor | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Staple, Implantable
- All makers of Stapler, Surgical
Updated September 7, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.