FDA 510(k)

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)

Número K: K203183 · 2021-05-06

Data da decisão2021-05-06

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) 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 K203183. 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 (30 cm shaft, 37 cm shaft, and 44 cm shaft)?

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) 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 K203183.

When did CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) receive FDA 510(k) clearance?

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) received FDA 510(k) clearance on 2021-05-06, under 510(k) number K203183.

Who is the listed applicant for CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)?

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 (30 cm shaft, 37 cm shaft, and 44 cm shaft)?

The FDA product code for CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) is GEI.

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

K231012CoolSeal Trinity K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (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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