FDA.report

510(k) K211579

Device
CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)
Applicant
Bolder Surgical, LLC
510(k) number
K211579
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-07
Date received
2021-05-21
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Nicholas Wong
Address
331 S. 104th St. Suite 200 Louisville CO US 80027 80027

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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