Cleared Traditional

ON-Q* Pump with Bolus

K181360 · Halyard Health · General Hospital
Mar 2019
Decision
304d
Days
Class 2
Risk

About This 510(k) Submission

K181360 is an FDA 510(k) clearance for the ON-Q* Pump with Bolus, a Pump, Infusion, Elastomeric (Class II — Special Controls, product code MEB), submitted by Halyard Health (Irvine, US). The FDA issued a Cleared decision on March 22, 2019, 304 days after receiving the submission on May 22, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K181360 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2018
Decision Date March 22, 2019
Days to Decision 304 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEB — Pump, Infusion, Elastomeric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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