Cleared Traditional

ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE

K122690 · Arrow International, Inc. · Anesthesiology

Dec 2012

Decision

108d

Days

Class 2

Risk

About This 510(k) Submission

K122690 is an FDA 510(k) clearance for the ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Arrow International, Inc. (Reading, US). The FDA issued a Cleared decision on December 21, 2012, 108 days after receiving the submission on September 4, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K122690 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 2012
Decision Date	December 21, 2012
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CAZ — Anesthesia Conduction Kit
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5140
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.