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Renova RP Centesis Pump

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221042

by GI Supply, Inc.

Identifiers

510(k) Number
K221042 FDA 510(k)
FDA Product Code
BTA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4780 FDA 510(k)
Regulation Number
878.4780 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Renova RP Centesis Pump is a portable, reusable suction pump designed to remove ascitic fluid from the abdominal cavity. It functions as a powered aspiration device intended to facilitate fluid drainage.

This device is used in conjunction with the Renova RP Tube Set and Renova RP Fluid Drainage Bags. It has received FDA 510K authorization and must be operated within the electromagnetic environment specified in the manufacturer's instruction manual.

Frequently asked questions

What is the primary function of the Renova RP Centesis Pump?

The Renova RP Centesis Pump is a portable, powered aspiration device designed to remove ascitic fluid from the abdominal cavity to facilitate fluid drainage.

Is the Renova RP Centesis Pump a single-use device?

No, the Renova RP Centesis Pump is designed as a reusable suction pump. However, it must be used in conjunction with specific accessories, including the Renova RP Tube Set and Renova RP Fluid Drainage Bags, to function correctly.

Are there specific environmental requirements for operating this pump?

Yes, the device must be operated within the specific electromagnetic environment detailed in the manufacturer's instruction manual to ensure proper performance and safety.

Has this device received regulatory authorization?

Yes, the Renova RP Centesis Pump has received FDA 510K authorization under the K-number K221042.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GI SUPPLY RENOVARP OPERATING MANUAL Pdf Download, GI SUPPLY RENOVARP OPERATING MANUAL Pdf Download, GI Supply RenovaRP Operating Manual | Manualzz, GI Supply, Inc. GIS-35 RenovaRP - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
GI Supply, Inc.

Sources (1)

  • FDA 510(k) K221042 24 fields · synced Sep 27, 2026