Cleared Traditional

SubQKath Catheter and Needle Set

K193664 · Hk Surgical · Anesthesiology
Sep 2020
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K193664 is an FDA 510(k) clearance for the SubQKath Catheter and Needle Set, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Hk Surgical (San Clemente, US). The FDA issued a Cleared decision on September 9, 2020, 253 days after receiving the submission on December 31, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K193664 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2019
Decision Date September 09, 2020
Days to Decision 253 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSO — Catheter, Conduction, Anesthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5120

Similar Devices — BSO Catheter, Conduction, Anesthetic

All 74
EDEN ControlCath
K241410 · Jmt Co., Ltd. · Feb 2025
Perifix FX Catheter; Contiplex FX Catheter
K231242 · B.Braun Medical, Inc. · Sep 2023
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 · Aug 2023
Percutaneous Introducer
K200624 · Epimed International, Inc. · Apr 2020
C-CAT Anaesthesia Catheter kit
K191470 · Cimpax Aps · Oct 2019
Medline Reinforced Epidural Catheter
K181782 · Medline Industries, Inc. · Mar 2019