Product Code: GCM FDA class 2 21 CFR 876.1500

Endoscope, Rigid

Gastroenterology, Urology

The Endoscope, Rigid (product code GCM) is a rigid tubular optical instrument used to visualize internal body cavities, organs, or surgical fields through natural orifices or small incisions, applicable across gastroenterological and urological procedures. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The device is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology specialty (GU). No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: GCM
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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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 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K203226	TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM	May 14, 2021	Substantially Equivalent	Richard Wolf Medical Instruments Corporation
K083840	MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE	Sep 28, 2009	Substantially Equivalent	Msi Medserv International Deutschland GmbH
K001217	INSIDE VIEW	Jul 11, 2000	Substantially Equivalent	Monadnock Optics, Inc.
K993103	ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES	Dec 10, 1999	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K993445	OMNISONIC ENDOSCOPIC DEFLECTOR	Dec 06, 1999	Substantially Equivalent	Omnisonics Medical Technologies
K962393	KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION	Sep 17, 1996	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K950712	PORTABLE ENDOSCOPY SYSTEM	May 14, 1996	Substantially Equivalent	Laser-Optik-Systeme GmbH & Co. KG
K955120	HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR	Jan 26, 1996	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K935235	ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY	Mar 23, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K945889	KARL STORZ PLASTIC SURGERY ACCESSORIES	Mar 22, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K931954	THORACOSCOPE/LAPAROSCOPE	Nov 02, 1993	Substantially Equivalent	Surgical Technologies, Inc.
K921918	FIBER OPTIC ENDOSCOPE	Aug 17, 1993	Substantially Equivalent	Electro Fiberoptics Corp.
K925918	PRESSURE TURING AND ACCESSORIES	Feb 12, 1993	Substantially Equivalent	Applied Medical Resources
K921883	ENDOSCOPE	Nov 23, 1992	Substantially Equivalent	Optimed Technologies, Inc.
K901464	MEDILASE SERIES 2200 ENDOSCOPE	Aug 07, 1990	Substantially Equivalent	Medical Laser, Inc.
K894592	LAMANO DIRECTORS	Sep 08, 1989	Substantially Equivalent	Marlo Surgical Technology
K853514	RIGID ENDOSCOPE	Oct 04, 1985	Substantially Equivalent	American Edwards Laboratories
K844769	RIGID FIBEROPITC ENDOSCOPE	Jan 15, 1985	Substantially Equivalent	Microvasive