510(k) Report

FDA applicant

Bolder Surgical, LLC

Louisville, CO5 decisions2020–20231 recall

FDA records 5 decisions for Bolder Surgical, LLC (Louisville, CO) from 2020 to 2023: 5 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 143 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Bolder Surgical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020: 12021: 32023: 1
2020high 3 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2020high 1 (2022) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Bolder Surgical, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bolder Surgical, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories5decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 143 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 146 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm…Bolder Surgical, LLC · 20202cite it
  • K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC · 20211cites it
  • K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)Bolder Surgical, LLC · 20211cites it

What has FDA decided for it lately?

  • K231012CoolSeal TrinityBolder Surgical, LLC · 2023
  • K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)Bolder Surgical, LLC · 2021
  • K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC · 2021
  • K203640CoolSeal RevealBolder Surgical, LLC · 2021
  • K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm…Bolder Surgical, LLC · 20201 recall

All 5 as Bolder Surgical, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K202114CoolSeal Generator, REF: CSL-200-50Jan 25, 2022Class II