Cleared Traditional

Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)

K230603 · Teleflex Medical · Anesthesiology

Aug 2023

Decision

180d

Days

Class 2

Risk

About This 510(k) Submission

K230603 is an FDA 510(k) clearance for the Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002), a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on August 30, 2023, 180 days after receiving the submission on March 3, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number	K230603 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 2023
Decision Date	August 30, 2023
Days to Decision	180 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF