Product Code: CCW FDA class 1 21 CFR 868.5540

Laryngoscope, Rigid

Anesthesiology

The Rigid Laryngoscope is an anesthesiology device with a non-flexible blade and handle used to directly visualize the larynx and facilitate orotracheal intubation, providing a clear line of sight to the vocal cords during airway management procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CCW, regulated under 21 CFR 868.5540, within the Anesthesiology medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

315

Registration Numbers

315

Unique Applicants

Years Active

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Basic Information

Product Code: CCW
Device Class: FDA class 1
Regulation Number: 868.5540
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 64 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K191602	APA Oxy Blade	Aug 02, 2019	Substantially Equivalent	Venner Medical (Singapore) Pte, Ltd.
K163412	Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)	Jun 22, 2017	Substantially Equivalent	Girgis Scope, LLC
K140951	YEESCOPE LARYNGOSCOPES	Nov 10, 2014	Substantially Equivalent	Yeescope Pty. , Ltd.
K121378	AIRTRAQ SP AIRTRAQ AVANT	Jun 21, 2012	Substantially Equivalent	Prodol Meditec , Ltd.
K063477	NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET	Feb 09, 2007	Substantially Equivalent	Novamed, LLC
K062523	TRU-MR LARYNGOSCOPE SET	Nov 17, 2006	Substantially Equivalent	Truphatek International, Ltd.
K062231	MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001	Aug 31, 2006	Substantially Equivalent	Minrad, Inc.
K062230	MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002	Aug 31, 2006	Substantially Equivalent	Minrad, Inc.
K041852	MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002	Nov 15, 2004	Substantially Equivalent	Minrad, Inc.
K984101	FLEXIBLADE	Sep 03, 1999	Substantially Equivalent	Arco Medic , Ltd.
K971377	GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE	Apr 30, 1998	Substantially Equivalent	Wilson Greatbatch Technologies, Inc.
K970619	GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE	Nov 19, 1997	Substantially Equivalent	Wilson Greatbatch Technologies, Inc.
K945590	SCOPETEX(TM)	May 20, 1997	Substantially Equivalent	Smith Helms Mulliss & Moore, L.L.P.
K961832	BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER	Sep 06, 1996	Substantially Equivalent	Blue Ridge Medical, Inc.
K945301	LARYNGOSCOPE COVER	May 31, 1996	Substantially Equivalent	Sotiria Mourkidou, M.D.
K954787	ILLUMINATOR	Jan 31, 1996	Substantially Equivalent	Hospitak, Inc.
K954446	AUGUSTINE INTUBATION GUIDE	Dec 29, 1995	Substantially Equivalent	Augustine Medical, Inc.
K954438	SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE	Dec 29, 1995	Substantially Equivalent	Rms Div.
K953179	CLM LARYNGOSCOPE	Oct 06, 1995	Substantially Equivalent	Penlon , Ltd.
K951147	LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER	Jun 08, 1995	Substantially Equivalent	Leigh Med Tech, Inc.
K951804	KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE	Jun 05, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K945425	MCINTOSH, MILLER, FOREGGER BABY	Mar 20, 1995	Substantially Equivalent	Rudolf Riester GmbH & Co. KG
K945901	DIRECT VIEW 2001 FIBERLIGHT	Dec 27, 1994	Substantially Equivalent	Mercury Medical
K944428	LITE-BLADE	Nov 15, 1994	Substantially Equivalent	Eare Consulting Service
K945269	OPTUS LARYNGOSCOPES	Nov 07, 1994	Substantially Equivalent	Optus, Inc.
K944686	FIBEROPTIC LARYNGOSCOPE HANDLE	Nov 04, 1994	Substantially Equivalent	Fiberoptic Medical Products, Inc.
K941319	THE WUSCOPE SYSTEM	Oct 04, 1994	Substantially Equivalent	Achi Corp.
K930804	FILLISCOPE	Oct 07, 1993	Substantially Equivalent	Filliscope, Inc.
K921263	SUNLITE LARYNGOSCOPE	Jun 01, 1993	Substantially Equivalent	Sunmed, Inc.
K926158	SLATER SLEEVE	Mar 19, 1993	Substantially Equivalent	Tadco, Inc.
K922019	LARYNGOSCOPE RIGID	Jan 26, 1993	Substantially Equivalent	Eastmed Enterprises, Inc.
K922275	UPSHERSCOPE(TM)	Jan 06, 1993	Substantially Equivalent	Upsher Laryngoscope Co.
K915161	AUGUSTINE FIBEROPTIC LARYNGOSCOPE	May 29, 1992	Substantially Equivalent	Augustine Medical, Inc.
K921166	AUGUSTINE GUIDE KIT	Apr 23, 1992	Substantially Equivalent	Augustine Medical, Inc.
K905273	BAUMAN DISPOSABLE LARYNGOSCOPE BLADES	Mar 24, 1992	Substantially Equivalent	Vital Signs, Inc.
K915804	PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM.	Mar 20, 1992	Substantially Equivalent	Propper Mfg. Co., Inc.
K914741	AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED	Feb 03, 1992	Substantially Equivalent	Eastmed Enterprises, Inc.
K914168	AUGUSTINE GUIDE KIT WITH GAUZE SPONGE	Oct 07, 1991	Substantially Equivalent	Augustine Medical, Inc.
K912905	LARYNGOSCOPE	Sep 30, 1991	Substantially Equivalent	Acorn Group, Inc.
K904918	BELSCOPE LARYNGOSCOPE	Jul 22, 1991	Substantially Equivalent	Avulunga Pty. , Ltd.
K901164	NEUSTEIN LARYNGOSCOPE	Oct 09, 1990	Substantially Equivalent	Neutech Corp.
K901680	BAUMAN RIGID LARYNGOSCOPE	Jul 12, 1990	Substantially Equivalent	Palex Intl. SA
K901489	MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE)	Apr 10, 1990	Substantially Equivalent	Eastmed Enterprises, Inc.
K895954	LARYNGOSTAT LARYNGOSCOPE HANDLE	Oct 30, 1989	Substantially Equivalent	Michigan Instruments, Inc.
K883830	FIBER OPTIC LARYNGOSCOPE	Oct 25, 1988	Substantially Equivalent	Effner, Inc.
K883819	BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P	Oct 17, 1988	Substantially Equivalent	Circon Acmi
K884073	LARYNGOSCOPE BLADE (ROBERTSHAW STYLE)	Oct 13, 1988	Substantially Equivalent	Eastmed Enterprises, Inc.
K883296	LARYNGOSCOPE	Oct 13, 1988	Substantially Equivalent	Lothar Scharras
K882433	LARYNGOSCOPE RIGID	Sep 02, 1988	Substantially Equivalent	Eastmed Enterprises, Inc.
K883414	LARYNGOSCOPE BLADES	Aug 19, 1988	Substantially Equivalent	Truphatek, Ltd.
K882930	LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX	Aug 16, 1988	Substantially Equivalent	Pilling Co.
K882659	AUGUSTINE INTUBATION GUIDE(TM)	Jul 21, 1988	Substantially Equivalent	Augustine Medical, Inc.
K872480	KAHN-TACT U.S.A., EFF LARYNGOSCOPE	Aug 10, 1987	Substantially Equivalent	Effner and Spreine Co.
K861026	LIBAN INTUBATOR	Jul 28, 1986	Substantially Equivalent	Life Support Devices Co.
K844776	EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN	Oct 01, 1985	Substantially Equivalent	Medical Instruments and Lamps
K851705	LARYNGOSCOPE	May 21, 1985	Substantially Equivalent	Armstrong Ind., Inc.
K841778	D.L. SCOPE BLADE & HANDLE	May 23, 1984	Substantially Equivalent	North American Medical Products, Inc.
K833055	LARYNGOSCOPE BLADES/HANDLES & LAMPS	Nov 14, 1983	Substantially Equivalent	Medovations, Inc.
K832984	DISPOSA-LITE LARYNGOSCOPE BLADE	Oct 28, 1983	Substantially Equivalent	Michael S. Upsher
K833133	DISPOSBLADE LARYNGOSCOPE	Oct 27, 1983	Substantially Equivalent	Geller & Bozeman
K831981	LARYNGESCOPE	Sep 29, 1983	Substantially Equivalent	W.E. Leder Enterprises, Inc.
K832650	UPSHER FIBERBRITE LARYNGOSCOPE	Sep 12, 1983	Substantially Equivalent	Michael S. Upsher
K830047	FIBER OPTIC LARYNGOSCOPES W/BATTERY	Jan 18, 1983	Substantially Equivalent	Welch Allyn, Inc.
K801452	OROTRACHEAL INTUBATION ENDOSCOPE	Jul 14, 1980	Substantially Equivalent	Olympus Corp.