Arrow Non-Stimulating SnapLock Adapter (K-05520-005C) +4 more— 510(k) K230603

Clearance details

Device name as filed

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)

Applicant

Teleflex Medical

Product code

Code BSO

Device class

Class 2

Regulation

21 CFR 868.5120

Advisory panel

Anesthesiology

Date received

2023-03-03

Decision date

2023-08-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Morrisville, NC, US

• K241410 — EDEN ControlCath2025-02-13
• K231242 — Perifix FX Catheter; Contiplex FX Catheter2023-09-15
• K193664 — SubQKath Catheter and Needle Set2020-09-09
• K200624 — Percutaneous Introducer2020-04-27
• K191470 — C-CAT Anaesthesia Catheter kit2019-10-25

• K251054 — Hem-o-lok PurplePlus Large Polymer Ligating Clips2025-07-03
• K242495 — LMA Fastrach ETT SU2025-04-29
• K243553 — QuikClot Control+ Hemostatic Device2025-03-18
• K241784 — Arrow® Nitinol Wire2024-09-18
• K233713 — Pilling Tracheostomy Tubes2024-03-22

Malfunction

688

Total

688

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →