Product Code: BSO FDA class 2 21 CFR 868.5120

Catheter, Conduction, Anesthetic

Anesthesiology

The Catheter, Conduction, Anesthetic is a flexible catheter used to deliver local anesthetic agents to a specific nerve or anatomical region for regional anesthesia or continuous nerve block. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BSO, regulated under 21 CFR 868.5120 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: BSO
Device Class: FDA class 2
Regulation Number: 868.5120
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 75 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241410	EDEN ControlCath	Feb 13, 2025	Substantially Equivalent	Jmt Co., Ltd.
K231242	Perifix FX Catheter; Contiplex FX Catheter	Sep 15, 2023	Substantially Equivalent	B.Braun Medical, Inc.
K230603	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)	Aug 30, 2023	Substantially Equivalent	Teleflex Medical
K193664	SubQKath Catheter and Needle Set	Sep 09, 2020	Substantially Equivalent	Hk Surgical
K200624	Percutaneous Introducer	Apr 27, 2020	Substantially Equivalent	Epimed International, Inc.
K191470	C-CAT Anaesthesia Catheter kit	Oct 25, 2019	Substantially Equivalent	Cimpax Aps
K181782	Medline Reinforced Epidural Catheter	Mar 04, 2019	Substantially Equivalent	Medline Industries, Inc.
K173541	EPINAUT	Aug 24, 2018	Substantially Equivalent	Imedicom Co., Ltd.
K172777	Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7	May 03, 2018	Substantially Equivalent	PAJUNK GmbH Medizintechnologie
K171584	B. Braun Tear-Away Introducer Needle	Dec 22, 2017	Substantially Equivalent	B.Braun Medical, Inc.
K171193	Certa Catheter	Dec 18, 2017	Substantially Equivalent	Ferrosan Medical Devices Sp. Z.O.O.
K162522	UltraCath Continuous Nerve block Catheter	Mar 17, 2017	Substantially Equivalent	Teleflexmedical, Inc.
K161232	ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit	Sep 30, 2016	Substantially Equivalent	Halyard Health
K153297	Perifix and Contiplex Catheter	Aug 12, 2016	Substantially Equivalent	B.Braun Medical, Inc.
K152952	E-Cath	Jul 13, 2016	Substantially Equivalent	PAJUNK GmbH Medizintechnologie
K150731	Medline Epidural Catheter	Mar 07, 2016	Substantially Equivalent	Medline Industries, Inc.
K150789	SPINAUT-E, SPINAUT-I	Mar 01, 2016	Substantially Equivalent	Imedicom Co., Ltd.
K140110	FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET	Mar 27, 2015	Substantially Equivalent	Teleflex, Inc.
K143164	ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set	Dec 02, 2014	Substantially Equivalent	Kimberly-Clark Corporation
K133316	SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)	May 28, 2014	Substantially Equivalent	Epimed International, Inc.
K122661	VITAL 5 RELEAF CATHETER	Feb 27, 2013	Substantially Equivalent	Vital 5
K111031	PAINFUSOR CATHETER	Jul 08, 2011	Substantially Equivalent	Plan 1 Health, S.R.L.
K110814	AMBIT TUNNELER	Apr 08, 2011	Substantially Equivalent	Summit Medical Products, Inc.
K102594	IO-FLEX CATHETER	Jan 19, 2011	Substantially Equivalent	Baxano, Inc.
K102460	AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH	Jan 13, 2011	Substantially Equivalent	Summit Medical Products, Inc.
K093920	BUSSE EPIDURAL CATHETER KIT	Aug 06, 2010	Substantially Equivalent	Busse Hospital Disposables
K090884	PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.	Jun 29, 2009	Substantially Equivalent	B.Braun Medical, Inc.
K081404	SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT	Oct 21, 2008	Substantially Equivalent	Spinal Integration, LLC
K080675	PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT	Jun 20, 2008	Substantially Equivalent	PAJUNK GmbH Medizintechnologie
K072702	STRYKER ANTIMIC CATHETER	Mar 19, 2008	Substantially Equivalent	Stryker Instruments, Instruments Div.
K072050	PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS	Oct 18, 2007	Substantially Equivalent	Life-Tech, Inc.
K070465	BUSSE EPIDURAL CATHETER	Jul 19, 2007	Substantially Equivalent	Busse Hospital Disposables, Inc.
K063234	ON-Q INTRODUCERS	Nov 21, 2006	Substantially Equivalent	I-Flow Corp.
K062005	PORTEX EPIDURAL CATHETER	Oct 18, 2006	Substantially Equivalent	Smiths Medical Asd, Inc.
K051401	ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER	Nov 30, 2005	Substantially Equivalent	I-Flow Corp.
K051524	LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216	Jul 07, 2005	Substantially Equivalent	Smiths Medical Asd, Inc.
K050557	AMT NANOCATH	May 27, 2005	Substantially Equivalent	American Medical Technologies, Inc.
K043456	MODIFICATION TO SOAKER CATHETER	Jan 11, 2005	Substantially Equivalent	I-Flow Corp.
K042488	PERIFIX CATHETER AND CONTIPLEX CATHETER	Sep 30, 2004	Substantially Equivalent	B.Braun Medical, Inc.
K032390	MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM	Aug 29, 2003	Substantially Equivalent	Ebi, L.P.
K023140	VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124	Aug 15, 2003	Substantially Equivalent	Epimed International, Inc.
K023233	EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM	Dec 13, 2002	Substantially Equivalent	Ebi, L.P.
K022019	PERIFIX CATHETER CONNECTOR	Aug 01, 2002	Substantially Equivalent	B.Braun Medical, Inc.
K991259	TE ME NA EPIDURAL CATHETER	Feb 21, 2001	Substantially Equivalent	Te ME NA S.A.R.L.
K000886	SPIROL EPIDURAL CATHETER	Oct 05, 2000	Substantially Equivalent	Abbott Laboratories
K001717	MICOR CONDUCTION CATHETER	Sep 20, 2000	Substantially Equivalent	Micor, Inc.
K993592	AXIOM MULTIPURPOSE WOUND DRAIN	May 17, 2000	Substantially Equivalent	Axiom Medical, Inc.
K991879	SPRING-WOUND EPIDURAL CATHETER	Oct 28, 1999	Substantially Equivalent	Micor, Inc.
K992471	SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18	Oct 22, 1999	Substantially Equivalent	Sims Portex, Inc.
K981329	FETH-R-KATH	Aug 26, 1998	Substantially Equivalent	Epimed International, Inc.
K971851	INTERPLEURAL ANESTHESIA CATHETER	Jan 22, 1998	Substantially Equivalent	Axiom Medical, Inc.
K951927	COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)	May 30, 1997	Substantially Equivalent	Csen , Ltd.
K954584	RACZ EPIDURAL CATHETER	Oct 08, 1996	Substantially Equivalent	Medic Evaluation Devices & Instruments Corp.
K951092	CATHETER SECUREMENT DEVICE	Mar 24, 1995	Substantially Equivalent	Baxter Healthcare Corp
K935927	CONCORD/PORTEX EPIDURAL CATHETERS	Sep 09, 1994	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K930539	MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY	Aug 27, 1993	Substantially Equivalent	Medical Components, Inc.
K930219	KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE	Apr 27, 1993	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K924995	4 SURE TM ANESTHESIA EXTENSION SET	Dec 30, 1992	Substantially Equivalent	Boston Pacific Medical, Inc.
K922113	KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATH	Dec 03, 1992	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K897194	PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL	Jun 18, 1990	Substantially Equivalent	Baxter Healthcare Corp
K896712	PHARMASEAL EPIDURAL CATHETER	Jun 18, 1990	Substantially Equivalent	Baxter Healthcare Corp
K901129	BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER	Mar 30, 1990	Substantially Equivalent	Medevice, Inc.
K895204	EPI-CATH(TM) EPIDURAL CATHETER	Nov 15, 1989	Substantially Equivalent	Abbott Laboratories
K884969	BIO-MATE(TM) EPIDURAL CATHETER	Jun 23, 1989	Substantially Equivalent	Medevice, Inc.
K863792	DURACATH, GISH MODEL NO. DVAC-XXXX	Dec 05, 1986	Substantially Equivalent	Gish Biomedical, Inc.
K854601	SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH	Jan 10, 1986	Substantially Equivalent	Concord Laboratories, Inc.
K850009	EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER	May 13, 1985	Substantially Equivalent	Vas-Cath of Canada , Ltd.
K850505	DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER	Mar 11, 1985	Substantially Equivalent	Parke-Davis Co.
K850439	DESERET EPIDURAL CATHETER	Mar 05, 1985	Substantially Equivalent	Parke-Davis Co.
K840202	EPIDURAL CATHETER	Feb 27, 1984	Substantially Equivalent	Aries Medical, Inc.
K832352	3-DAY RELEASE OF ETHYLENE OXIDE DEVICE	Jan 13, 1984	Substantially Equivalent	Parke-Davis Co.
K832232	EPINEED EPIDURAL CATHETER	Aug 08, 1983	Substantially Equivalent	Terumo Medical Corp.
K823702	EPIDURAL CATHETER	Jan 07, 1983	Substantially Equivalent	Rsp, Inc.
K822436	DNA MEDICAL DURACATH	Oct 22, 1982	Substantially Equivalent	Moorehead Hospital Products, Inc.
K802065	CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG	Sep 09, 1980	Substantially Equivalent	Portex, Inc.