FDA 510(k)

CoolSeal Reveal

N.º K: K203640 · 2021-05-06

Fecha de decisión2021-05-06

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

CoolSeal Reveal is the device name listed in this FDA 510(k) record. The listed applicant is Bolder Surgical, LLC. It received FDA 510(k) clearance on 2021-05-06 under 510(k) number K203640. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CoolSeal Reveal?

CoolSeal Reveal is a medical device that received FDA 510(k) clearance on 2021-05-06. The listed applicant is Bolder Surgical, LLC. The 510(k) number is K203640.

When did CoolSeal Reveal receive FDA 510(k) clearance?

CoolSeal Reveal received FDA 510(k) clearance on 2021-05-06, under 510(k) number K203640.

Who is the listed applicant for CoolSeal Reveal?

The FDA 510(k) record lists Bolder Surgical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoolSeal Reveal?

The FDA product code for CoolSeal Reveal is GEI.

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Otros registros que enlistan a Bolder Surgical, LLC como solicitante

K231012CoolSeal Trinity K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)K202114CoolSeal 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

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Fuente oficial

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