FDA 510(k)

BenestaTM Tissue Removal Device

N.º K: K192811 · 2020-10-23

Fecha de decisión2020-10-23

Código de productoHIH

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Caldera Medical, Inc. como solicitante

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

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: HIH)

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)Karl Storz SE & CO. KG K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.