Cleared Traditional

K221518 - NP Medical nCompass Extension Set with Stabilizing Base
(FDA 510(k) Clearance)

K221518 · Np Medical · General Hospital

Nov 2022

Decision

162d

Days

Class 2

Risk

K221518 is an FDA 510(k) clearance for the NP Medical nCompass Extension Set with Stabilizing Base. This device is classified as a Set, Administration, Intravascular (Class II — Special Controls, product code FPA).

Submitted by Np Medical (Clinton, US). The FDA issued a Cleared decision on November 3, 2022, 162 days after receiving the submission on May 25, 2022.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K221518 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 25, 2022
Decision Date	November 03, 2022
Days to Decision	162 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF