Product Code: FWF FDA class 1 21 CFR 878.4160

Camera, Television, Endoscopic, Without Audio

General, Plastic Surgery

An endoscopic television camera without audio is a video imaging device integrated with or attached to an endoscope to capture real-time images of internal structures during minimally invasive surgical procedures, without audio. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FWF, regulated under 21 CFR 878.4160, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

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Basic Information

Product Code: FWF
Device Class: FDA class 1
Regulation Number: 878.4160
Medical Specialty: General, Plastic Surgery
Review Panel: SU
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 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K053412	FLEXISCOPE, MODELS 50MH AND 50 MHC	Feb 23, 2006	Substantially Equivalent	Schoelly Imaging, Inc.
K990154	KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM	Jun 01, 1999	Substantially Equivalent	Karl Storz Imaging, Inc.
K982754	EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)	Jan 08, 1999	Substantially Equivalent	A.Stein - Regulatory Affairs Consulting
K982965	ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES	Nov 23, 1998	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K982397	VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM	Sep 10, 1998	Substantially Equivalent	Angiolaz, Inc.
K982409	VES 1501-M	Aug 21, 1998	Substantially Equivalent	Angiolaz, Inc.
K981819	ANGIOLAZ VES-1CAM	Aug 04, 1998	Substantially Equivalent	Angiolaz, Inc.
K944707	ISOLATED CAMERA HEAD	Oct 07, 1994	Substantially Equivalent	Envision Medical Corp.
K930297	FUJINON VIDEO LAPAROSCOPE, MODIFIED	Mar 29, 1994	Substantially Equivalent	Fujinon, Inc.
K934682	SURGICAL VIDEO CAMERA AND ACCESSORIES	Feb 15, 1994	Substantially Equivalent	Medical Dynamics, Inc.
K932628	ENDOSCOPIC VIDEO CAMERA	Oct 15, 1993	Substantially Equivalent	Stephen Chakoff, Inc.
K926166	COAST VIDEO ENDOSCOPIC IMAGING SYSTEM	Jun 01, 1993	Substantially Equivalent	Optik
K930053	VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10	May 17, 1993	Substantially Equivalent	Medical Devices, Inc.
K925108	INTEGRATED VISUALIZATION SYSTEM	Jan 29, 1993	Substantially Equivalent	Neuro Navigational Corp.
K923160	3DSCOPE	Dec 10, 1992	Substantially Equivalent	American Surgical Technologies Corp.
K911163	IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS	Jun 03, 1991	Substantially Equivalent	Imagyn Medical, Inc.
K905393	HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR	Jan 16, 1991	Substantially Equivalent	Frigitronics, Inc.
K881014	THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM	Apr 14, 1988	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K872661	RGB CAMERA SYSTEM	Jul 21, 1987	Substantially Equivalent	Aspen Laboratories, Inc.
K871056	MEDICAM S-4 SURGICAL CAMERA	Mar 31, 1987	Substantially Equivalent	M.P. Video, Inc.
K863598	VIDEO CAMERA SYSTEM	Oct 02, 1986	Substantially Equivalent	American Edwards Laboratories
K863376	MODEL MC-1 SURGICAL VIDEO CAMERA	Oct 02, 1986	Substantially Equivalent	Biometric Products, Inc.
K834069	ARTHROSCAN VIDEO SYSTEM	Jan 27, 1984	Substantially Equivalent	Concept, Inc.