CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)— 510(k) K211579

Substantially Equivalent

Bolder Surgical, LLC

FDA 510(k) clearance K211579 for CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft), Substantially Equivalent on 2021-09-07. Applicant: Bolder Surgical, LLC.

Clearance details

Applicant: Bolder Surgical, LLC
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2021-05-21
Decision date: 2021-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.