FWF — Camera, Television, Endoscopic, Without Audio Class I
FDA product code FWF covers "Camera, Television, Endoscopic, Without Audio", a Class I medical device regulated under 21 CFR 878.4160. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FWF
- Device Class
- Class I
- Regulation Number
- 878.4160
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K053412 | schoelly imaging | FLEXISCOPE, MODELS 50MH AND 50 MHC | February 23, 2006 |
| K990154 | karl storz imaging | KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM | June 1, 1999 |
| K982754 | a.stein - regulatory affairs consulting | EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N ( | January 8, 1999 |
| K982965 | richard wolf medical instruments | ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES | November 23, 1998 |
| K982397 | angiolaz | VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM | September 10, 1998 |
| K982409 | angiolaz | VES 1501-M | August 21, 1998 |
| K981819 | angiolaz | ANGIOLAZ VES-1CAM | August 4, 1998 |
| K944707 | envision medical | ISOLATED CAMERA HEAD | October 7, 1994 |
| K930297 | fujinon | FUJINON VIDEO LAPAROSCOPE, MODIFIED | March 29, 1994 |
| K934682 | medical dynamics | SURGICAL VIDEO CAMERA AND ACCESSORIES | February 15, 1994 |
| K932628 | stephen chakoff | ENDOSCOPIC VIDEO CAMERA | October 15, 1993 |
| K926166 | optik | COAST VIDEO ENDOSCOPIC IMAGING SYSTEM | June 1, 1993 |
| K930053 | medical devices | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 | May 17, 1993 |
| K925108 | neuro navigational | INTEGRATED VISUALIZATION SYSTEM | January 29, 1993 |
| K923160 | american surgical technologies | 3DSCOPE | December 10, 1992 |
| K911163 | imagyn medical | IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS | June 3, 1991 |
| K905393 | frigitronics | HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR | January 16, 1991 |
| K881014 | karl storz endoscopy-america | THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM | April 14, 1988 |
| K872661 | aspen laboratories | RGB CAMERA SYSTEM | July 21, 1987 |
| K871056 | m.p. video | MEDICAM S-4 SURGICAL CAMERA | March 31, 1987 |