Product Code: BSR FDA class 1 21 CFR 868.5790

Stylet, Tracheal Tube

Anesthesiology

The Stylet, Tracheal Tube is a malleable wire or rod inserted into a tracheal tube to provide stiffness and allow the clinician to shape the tube for easier intubation of the airway. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BSR, regulated under 21 CFR 868.5790 in the Anesthesiology specialty.

View on FDA

510(k)s

FEI Numbers

133

Registration Numbers

133

Unique Applicants

Years Active

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Basic Information

Product Code: BSR
Device Class: FDA class 1
Regulation Number: 868.5790
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

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 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K162729	Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip	Aug 11, 2017	Substantially Equivalent	Cook Incorporated
K962361	TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND	Sep 05, 1996	Substantially Equivalent	Laerdal Medical Corp.
K954771	TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)	May 09, 1996	Substantially Equivalent	Laerdal Medical Corp.
K943104	MOLLOY INTUBATING STYLETTE	Apr 18, 1996	Substantially Equivalent	Molloy Corp.
K955238	RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE	Feb 06, 1996	Substantially Equivalent	Rusch Intl.
K953677	LIGHTED FLEXGUIDE (MODIFICATION)	Aug 25, 1995	Substantially Equivalent	Scientific Sales Intl., Inc.
K952100	RUSCH ENDOTRACHEAL TUBE STYLET	Aug 08, 1995	Substantially Equivalent	Rusch, Inc.
K952266	SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE	Jun 12, 1995	Substantially Equivalent	Stebar Instrument Corp.
K950713	AIRGUIDE STYLETTE	May 17, 1995	Substantially Equivalent	Polamedco, Inc.
K950380	FLEXTITIP STYLETTE	Feb 10, 1995	Substantially Equivalent	Polamedco, Inc.
K944729	STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE	Dec 21, 1994	Substantially Equivalent	Coast Medical, Inc.
K940799	FLEXGUIDE	Aug 18, 1994	Substantially Equivalent	Scientific Sales Intl., Inc.
K933598	ENDOSTAR(TM) STYLET	Jan 25, 1994	Substantially Equivalent	Fiberoptic Medical Products, Inc.
K935797	SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE	Jan 12, 1994	Substantially Equivalent	Stebar Instrument Corp.
K932081	LIGHTED INTUBATION SYLET	Jul 27, 1993	Substantially Equivalent	Aaron Medical, Inc.
K904999	WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE	Jan 26, 1993	Substantially Equivalent	Opticon Medical, Inc.
K922842	STYLET AND TRACHEAL LIGHTWAND (STL)	Dec 18, 1992	Substantially Equivalent	Laerdal California, Inc.
K921128	ENDOTRACHEAL TUBE STYLET	Jun 02, 1992	Substantially Equivalent	Eastmed Enterprises, Inc.
K914965	DISPOSABLE STYLETTE WITH END CAP	May 27, 1992	Substantially Equivalent	Pivic Promedco
K920468	AUGUSTINE STYLET	Apr 23, 1992	Substantially Equivalent	Augustine Medical, Inc.
K912690	AUGUSTINE GUIDE(TM) KIT	Sep 04, 1991	Substantially Equivalent	Augustine Medical, Inc.
K910659	AUGUSTINE STYLET	May 17, 1991	Substantially Equivalent	Augustine Medical, Inc.
K905133	STYLET TRACHAEL TUBE	Apr 22, 1991	Substantially Equivalent	Medical Devices, Inc.
K905052	BIVONA ENDOTRACHEAL TUBE STYLET	Apr 02, 1991	Substantially Equivalent	Bivona Medical Technologies
K902180	TRACHEAL TUBE STYLET	Jul 19, 1990	Substantially Equivalent	Sims Surgical, Inc.
K865108	N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE	Feb 10, 1987	Substantially Equivalent	Ackrad Laboratories
K844557	ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE	Dec 17, 1984	Substantially Equivalent	Ackrad Laboratories
K843490	TUBE-STAT	Oct 04, 1984	Substantially Equivalent	Concept, Inc.
K832773	SHERI-I-SLIP INTUBATING STYLET	Sep 12, 1983	Substantially Equivalent	Sheridan Catheter Corp.
K802416	SALEM/RESCE INTUBATION GUIDE	Oct 23, 1980	Substantially Equivalent	Scientific Sales Intl., Inc.
K772046	INTUBATION PROCEDURE KIT	Nov 23, 1977	Substantially Equivalent	American Hospital Supply Corp.
K770374	STYLETTE, SLICK, CAT. NO. 2000B	Mar 30, 1977	Substantially Equivalent	Medical Products Div. P.O.L.A. Plasti