Product Code: GCI FDA class 2 21 CFR 876.1500

Laryngoscope, Endoscope

Gastroenterology, Urology

The Laryngoscope, Endoscope (product code GCI) is an endoscopic instrument used to visualize the larynx and vocal cords for diagnostic or interventional purposes, including intubation assistance, biopsy, or removal of foreign bodies. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. The device is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology specialty (GU). It is eligible for review by an FDA-accredited third-party reviewer.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GCI
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: SU
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 14 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K021747	DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR	Aug 15, 2002	Substantially Equivalent	Surgicon, Inc.
K003222	MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER	Nov 03, 2000	Substantially Equivalent	Computer Motion, Inc.
K001362	KARL STORZ 3D VIDEO SYSTEM	Jul 17, 2000	Substantially Equivalent	Karl Storz Imaging, Inc.
K933515	BOOTY ENDOSCOPE WARMER	Oct 27, 1993	Substantially Equivalent	T-Med, Inc.
K930302	BIRTCHER SURE CLEAN INSTRUMENT SYSTEM	Oct 27, 1993	Substantially Equivalent	Birtcher Medical Systems, Inc.
K930496	GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS	Apr 20, 1993	Substantially Equivalent	Birtcher Medical Systems, Inc.
K922123	AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH	Feb 01, 1993	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K920139	GLEESON CLOT-BUSTER	Apr 15, 1992	Substantially Equivalent	Conmedcorp
K915762	POOLE TIP SUCTION PROBE	Mar 13, 1992	Substantially Equivalent	O.R. Concepts, Inc.
K914120	SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT	Oct 30, 1991	Substantially Equivalent	Conmedcorp
K911829	ENDOSTAPLE	Aug 28, 1991	Substantially Equivalent	ETHICON, Inc.
K911461	SURGITRON	Apr 25, 1991	Substantially Equivalent	Ellman Intl. Mfg., Inc.
K905117	ENDOSCOPE AND ACCESSORIES	Apr 25, 1991	Substantially Equivalent	Northgate Technologies, Inc.
K896205	MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE	Mar 22, 1990	Substantially Equivalent	Dexide, Inc.