FDA 510(k)

BenestaTM Tissue Removal Device

Número K: K192811 · 2020-10-23

Data da decisão2020-10-23

Código do produtoHIH

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

BenestaTM Tissue Removal Device is the device name listed in this FDA 510(k) record. The listed applicant is Caldera Medical, Inc.. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K192811. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BenestaTM Tissue Removal Device?

BenestaTM Tissue Removal Device is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K192811.

When did BenestaTM Tissue Removal Device receive FDA 510(k) clearance?

BenestaTM Tissue Removal Device received FDA 510(k) clearance on 2020-10-23, under 510(k) number K192811.

Who is the listed applicant for BenestaTM Tissue Removal Device?

The FDA 510(k) record lists Caldera Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BenestaTM Tissue Removal Device?

The FDA product code for BenestaTM Tissue Removal Device is HIH.

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Outros registros que listam Caldera Medical, Inc. como candidato(a)

K233500Benesta Tissue Removal Device K211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System K192822Benesta Hysteroscope K193603Benesta Medical Sterilization Tray K191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack K172614Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left

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Fonte oficial

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