Bolder Surgical, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Bolder Surgical, LLC” (first 2020, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 143 days. Since 2017 the median was 143 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Hologic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 68 |
| 2021 | 3 | 143 |
| 2022 | 0 | — |
| 2023 | 1 | 219 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bolder Surgical, LLC took a median 143 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 5 |
Review panels
Most recent Bolder Surgical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231012 | CoolSeal Trinity | GEI | 2023-11-15 | 219 |
| K211579 | CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) | GEI | 2021-09-07 | 109 |
| K203640 | CoolSeal Reveal | GEI | 2021-05-06 | 143 |
| K203183 | CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) | GEI | 2021-05-06 | 191 |
| 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 | 2020-10-06 | 68 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-01-25.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bolder Surgical, LLC?
FDA lists 5 510(k) clearances under the applicant name “Bolder Surgical, LLC” (first 2020, latest 2023), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bolder Surgical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bolder Surgical, LLC is 143 days. Since 2017: 143 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bolder Surgical, LLC?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 5).
Next steps
- See all 5 Bolder Surgical, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEI, Bolder Surgical, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.