Chrysalis Intelligence · Sponsors · Bolder Surgical, LLC

Bolder Surgical, LLC

Louisville, CO, US · 5 510(k) clearances · 1 recalls

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Total clearances
5
2020-10-06 → 2023-11-15
Last 12 months
0
Product codes
1
Most recent
2023-11-15
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 5 2023-11-15
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2022-01-25
DateSeverityStatusRecall # ProductCodeReason
2022-01-25 Class II Terminated 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…
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2023-11-15 K231012 CoolSeal Trinity GEI Class II General, Plastic Surgery
2021-09-07 K211579 CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) GEI Class II General, Plastic Surgery
2021-05-06 K203640 CoolSeal Reveal GEI Class II General, Plastic Surgery
2021-05-06 K203183 CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) GEI Class II General, Plastic Surgery
2020-10-06 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 Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence