CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)— 510(k) K211579
Substantially EquivalentBolder 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. Device class: 2.
Clearance details
- Applicant
- Bolder Surgical, LLC
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, CO, US
Recent devices under product code GEI
view allMore clearances from Bolder Surgical, LLC
view all- K231012 — CoolSeal Trinity
- K203183 — CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
- K203640 — CoolSeal Reveal
- 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
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, through . 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.