FDA 510(k)

CoolSeal Trinity

Número K: K231012 · 2023-11-15

Data da decisão2023-11-15

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CoolSeal Trinity 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 2023-11-15 under 510(k) number K231012. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CoolSeal Trinity?

CoolSeal Trinity is a medical device that received FDA 510(k) clearance on 2023-11-15. The listed applicant is Bolder Surgical, LLC. The 510(k) number is K231012.

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

CoolSeal Trinity received FDA 510(k) clearance on 2023-11-15, under 510(k) number K231012.

Who is the listed applicant for CoolSeal Trinity?

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 Trinity?

The FDA product code for CoolSeal Trinity is GEI.

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Outros registros que listam Bolder Surgical, LLC como candidato(a)

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)K203640CoolSeal Reveal 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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Fonte oficial

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