FWF · Camera, Television, Endoscopic, Without Audio
General, Plastic Surgery · 21 CFR 878.4160 · Class 1
Overview
| Product Code | FWF |
|---|---|
| Device Name | Camera, Television, Endoscopic, Without Audio |
| Regulation | 21 CFR 878.4160 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A surgical camera and accessories is a device intended to be used to record operative procedures.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K053412 | FLEXISCOPE, MODELS 50MH AND 50 MHC | Schoelly Imaging, Inc. | Feb 23, 2006 | SESE |
| K990154 | KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM | Karl Storz Imaging, Inc. | Jun 1, 1999 | SESE |
| K982754 | EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) | A.Stein - Regulatory Affairs Consulting | Jan 8, 1999 | SESE |
| K982965 | ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES | Richard Wolf Medical Instruments Corp. | Nov 23, 1998 | SESE |
| K982397 | VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM | Angiolaz, Inc. | Sep 10, 1998 | SESE |
| K982409 | VES 1501-M | Angiolaz, Inc. | Aug 21, 1998 | SESE |
| K981819 | ANGIOLAZ VES-1CAM | Angiolaz, Inc. | Aug 4, 1998 | SESE |
| K944707 | ISOLATED CAMERA HEAD | Envision Medical Corp. | Oct 7, 1994 | SESE |
| K930297 | FUJINON VIDEO LAPAROSCOPE, MODIFIED | Fujinon, Inc. | Mar 29, 1994 | SESE |
| K934682 | SURGICAL VIDEO CAMERA AND ACCESSORIES | Medical Dynamics, Inc. | Feb 15, 1994 | SESE |
| K932628 | ENDOSCOPIC VIDEO CAMERA | Stephen Chakoff, Inc. | Oct 15, 1993 | SESE |
| K926166 | COAST VIDEO ENDOSCOPIC IMAGING SYSTEM | Optik | Jun 1, 1993 | SESE |
| K930053 | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 | Medical Devices, Inc. | May 17, 1993 | SESE |
| K925108 | INTEGRATED VISUALIZATION SYSTEM | Neuro Navigational Corp. | Jan 29, 1993 | SESE |
| K923160 | 3DSCOPE | American Surgical Technologies Corp. | Dec 10, 1992 | SESE |
| K911163 | IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS | Imagyn Medical, Inc. | Jun 3, 1991 | SESE |
| K905393 | HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR | Frigitronics, Inc. | Jan 16, 1991 | SESE |
| K881014 | THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM | KARL STORZ Endoscopy-America, Inc. | Apr 14, 1988 | SESE |
| K872661 | RGB CAMERA SYSTEM | Aspen Laboratories, Inc. | Jul 21, 1987 | SESE |
| K871056 | MEDICAM S-4 SURGICAL CAMERA | M.P. Video, Inc. | Mar 31, 1987 | SESE |
Top Applicants
- Angiolaz, Inc. — 3 clearances
- A.Stein - Regulatory Affairs Consulting — 1 clearance
- American Edwards Laboratories — 1 clearance
- American Surgical Technologies Corp. — 1 clearance
- Aspen Laboratories, Inc. — 1 clearance
