Atlas FDA

FWF

23 FDA 510(k) clearances · Product code

78 daysmedian time to decision
164 days90th percentile
23clearances measured

FDA profile

Official device name
Camera, Television, Endoscopic, Without Audio
Device class
Class I (low risk)
Regulation
21 CFR 878.4160
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 28 · 2022: 40 · 2023: 25 · 2024: 20 · 2025: 28 · 2026: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
FLEXISCOPE, MODELS 50MH AND 50 MHC (K053412)Schoelly Imaging, Inc.2006-02-23
KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM (K990154)Karl Storz Imaging, Inc.1999-06-01
EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) (K982754)A.Stein - Regulatory Affairs Consulting1999-01-08
ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES (K982965)Richard Wolf Medical Instruments Corp.1998-11-23
VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM (K982397)Angiolaz, Inc.1998-09-10
VES 1501-M (K982409)Angiolaz, Inc.1998-08-21
ANGIOLAZ VES-1CAM (K981819)Angiolaz, Inc.1998-08-04
ISOLATED CAMERA HEAD (K944707)Envision Medical Corp.1994-10-07
FUJINON VIDEO LAPAROSCOPE, MODIFIED (K930297)Fujinon, Inc.1994-03-29
SURGICAL VIDEO CAMERA AND ACCESSORIES (K934682)Medical Dynamics, Inc.1994-02-15
ENDOSCOPIC VIDEO CAMERA (K932628)Stephen Chakoff, Inc.1993-10-15
COAST VIDEO ENDOSCOPIC IMAGING SYSTEM (K926166)Optik1993-06-01
VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 (K930053)Medical Devices, Inc.1993-05-17
INTEGRATED VISUALIZATION SYSTEM (K925108)Neuro Navigational Corp.1993-01-29
3DSCOPE (K923160)American Surgical Technologies Corp.1992-12-10
IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS (K911163)Imagyn Medical, Inc.1991-06-03
HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR (K905393)Frigitronics, Inc.1991-01-16
THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM (K881014)KARL STORZ Endoscopy-America, Inc.1988-04-14
RGB CAMERA SYSTEM (K872661)Aspen Laboratories, Inc.1987-07-21
MEDICAM S-4 SURGICAL CAMERA (K871056)M.P. Video, Inc.1987-03-31
VIDEO CAMERA SYSTEM (K863598)American Edwards Laboratories1986-10-02
MODEL MC-1 SURGICAL VIDEO CAMERA (K863376)Biometric Products, Inc.1986-10-02
ARTHROSCAN VIDEO SYSTEM (K834069)Concept, Inc.1984-01-27

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Every clearance here is in the API, with alerts when new ones post.