FDA 510(k)

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

N.º K: K232130 · 2023-12-15

SolicitanteSurgical Instrument Services and Savings, Inc.

Fecha de decisión2023-12-15

Código de productoOWQ

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Services and Savings, Inc.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K232130. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter?

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Surgical Instrument Services and Savings, Inc.. The 510(k) number is K232130.

When did Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter receive FDA 510(k) clearance?

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter received FDA 510(k) clearance on 2023-12-15, under 510(k) number K232130.

Who is the listed applicant for Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter?

The FDA 510(k) record lists Surgical Instrument Services and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter?

The FDA product code for Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is OWQ.

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Otros registros que enlistan a Surgical Instrument Services and Savings, Inc. como solicitante

K162751Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider K152313Medline ReNewal Reprocessed Endopath Endoscopic Instruments

Dispositivos relacionados (Código: OWQ)

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Fuente oficial

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