FDA.report

Product code FWF

Product
Camera, Television, Endoscopic, Without Audio
Definition
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Description
General & Plastic Surgery TV Receivers & Products Containing Same
Regulation number
878.4160
Radiation type
Ionizing
Applicable standards
Television Receivers. [1020.10]

Current FDA Classification

Device name
Camera, Television, Endoscopic, Without Audio
Medical specialty
General, Plastic Surgery
Device class
1
Regulation number
878.4160
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related Records

Related 510(k) Records

510(k)DeviceApplicantDecision date
K053412FLEXISCOPE, MODELS 50MH AND 50 MHCSchoelly Imaging, Inc.2006-02-23
K990154KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEMKarl Storz Imaging, Inc.1999-06-01
K982754EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)A.Stein - Regulatory Affairs Consulting1999-01-08
K982965ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIESRichard Wolf Medical Instruments Corp.1998-11-23
K982397VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEMAngiolaz, Inc.1998-09-10
K982409VES 1501-MAngiolaz, Inc.1998-08-21
K981819ANGIOLAZ VES-1CAMAngiolaz, Inc.1998-08-04
K944707ISOLATED CAMERA HEADEnvision Medical Corp.1994-10-07
K930297FUJINON VIDEO LAPAROSCOPE, MODIFIEDFujinon, Inc.1994-03-29
K934682SURGICAL VIDEO CAMERA AND ACCESSORIESMedical Dynamics, Inc.1994-02-15
K932628ENDOSCOPIC VIDEO CAMERAStephen Chakoff, Inc.1993-10-15
K926166COAST VIDEO ENDOSCOPIC IMAGING SYSTEMOptik1993-06-01
K930053VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10Medical Devices, Inc.1993-05-17
K925108INTEGRATED VISUALIZATION SYSTEMNeuro Navigational Corp.1993-01-29
K9231603DSCOPEAmerican Surgical Technologies Corp.1992-12-10
K911163IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESSImagyn Medical, Inc.1991-06-03
K905393HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSORFrigitronics, Inc.1991-01-16
K881014THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAMKARL STORZ Endoscopy-America, Inc.1988-04-14
K872661RGB CAMERA SYSTEMAspen Laboratories, Inc.1987-07-21
K871056MEDICAM S-4 SURGICAL CAMERAM.P. Video, Inc.1987-03-31
K863598VIDEO CAMERA SYSTEMAmerican Edwards Laboratories1986-10-02
K863376MODEL MC-1 SURGICAL VIDEO CAMERABiometric Products, Inc.1986-10-02
K834069ARTHROSCAN VIDEO SYSTEMConcept, Inc.1984-01-27

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