# Bolder Surgical, LLC

- Location (FDA's records): Louisville, CO
- FDA decisions: 5 (2020–2023): 5 510(k) clearances
- Product codes: GEI (5)
- 510(k) review time since 2016: median 143 days, against 146 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Justright Surgical, LLC: 3 (https://510kreport.com/company/justright-surgical)
- Covidien: 3 (https://510kreport.com/company/covidien)

## Firms that cite its devices most
- Hologic, Inc.: 1 (https://510kreport.com/company/hologic)

## Its most-cited devices
- 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 (2020), cited by 2
- K203183: CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) (2021), cited by 1
- K211579: CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) (2021), cited by 1

## Recent decisions
- K231012: CoolSeal Trinity (Nov 15, 2023)
- K211579: CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) (Sep 7, 2021)
- K203183: CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) (May 6, 2021)
- K203640: CoolSeal Reveal (May 6, 2021)
- 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 (Oct 6, 2020)

Source page: https://510kreport.com/company/bolder-surgical