Cleared Traditional

K221042 - Renova RP Centesis Pump (FDA 510(k) Clearance)

K221042 · Gi Supply, Inc. · General & Plastic Surgery device

Apr 2023

Decision

376d

Days

Class 2

Risk

K221042 is an FDA 510(k) clearance for the Renova RP Centesis Pump. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).

Submitted by Gi Supply, Inc. (Mechanicsburg, US). The FDA issued a Cleared decision on April 19, 2023, 376 days after receiving the submission on April 8, 2022.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number	K221042 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 08, 2022
Decision Date	April 19, 2023
Days to Decision	376 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF