Camera, Television, Endoscopic, Without Audio
FDA product code FWF · Class I (low risk) · 21 CFR 878.4160 · General, Plastic Surgery
23510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Angiolaz, Inc. 3
- Medical Devices, Inc. 1
- Schoelly Imaging, Inc. 1
- Karl Storz Imaging, Inc. 1
- A.Stein - Regulatory Affairs Consulting 1
- Richard Wolf Medical Instruments Corp. 1
- Envision Medical Corp. 1
- Fujinon, Inc. 1
- Medical Dynamics, Inc. 1
- Stephen Chakoff, Inc. 1
- Optik 1
- Concept, Inc. 1
- Neuro Navigational Corp. 1
- American Surgical Technologies Corp. 1
- Imagyn Medical, Inc. 1
- Frigitronics, Inc. 1
- KARL STORZ Endoscopy-America, Inc. 1
- Aspen Laboratories, Inc. 1
- M.P. Video, Inc. 1
- American Edwards Laboratories 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053412 | Flexiscope, Models 50MH and 50 MHCFWF · Traditional | Schoelly Imaging, Inc. | 02/23/2006SE |
| K990154 | Karl Storz Direct Coupled Interface (Dci 5) Camera SystemFWF · Traditional | Karl Storz Imaging, Inc. | 06/01/1999SE |
| K982754 | EC-1000-7 Digital Endoscopy Video Camera, Models Ec 1000-7P (Pal) & Ec 1000-7N (NTSC)FWF · Traditional | A.Stein - Regulatory Affairs Consulting | 01/08/1999SE |
| K982965 | Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesFWF · Traditional | Richard Wolf Medical Instruments Corp. | 11/23/1998SE |
| K982397 | Ves 3001-M Complete Video Endoscopic SystemFWF · Traditional | Angiolaz, Inc. | 09/10/1998SE |
| K982409 | Ves 1501-MFWF · Traditional | Angiolaz, Inc. | 08/21/1998SE |
| K981819 | Angiolaz VES-1CAMFWF · Traditional | Angiolaz, Inc. | 08/04/1998SE |
| K944707 | Isolated Camera HeadFWF · Traditional | Envision Medical Corp. | 10/07/1994SE |
| K930297 | Fujinon Video Laparoscope, ModifiedFWF · Traditional | Fujinon, Inc. | 03/29/1994SE |
| K934682 | Surgical Video Camera and AccessoriesFWF · Traditional | Medical Dynamics, Inc. | 02/15/1994SE |
| K932628 | Endoscopic Video CameraFWF · Traditional | Stephen Chakoff, Inc. | 10/15/1993SE |
| K926166 | Coast Video Endoscopic Imaging SystemFWF · Traditional | Optik | 06/01/1993SE |
| K930053 | Video Camera W/ Electronic Shutter Model VCE-10FWF · Traditional | Medical Devices, Inc. | 05/17/1993SE |
| K925108 | Integrated Visualization SystemFWF · Traditional | Neuro Navigational Corp. | 01/29/1993SE |
| K923160 | 3DSCOPEFWF · Traditional | American Surgical Technologies Corp. | 12/10/1992SE |
| K911163 | Imagyn Medical Videoscopy Syst W/Irrig Pump/AccessFWF · Traditional | Imagyn Medical, Inc. | 06/03/1991SE |
| K905393 | Hc-Series Medical Camera/Light Source and AccessorFWF · Traditional | Frigitronics, Inc. | 01/16/1991SE |
| K881014 | The Karl Storz Mini 9000 Solid State CCD Video CamFWF · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/14/1988SE |
| K872661 | RGB Camera SystemFWF · Traditional | Aspen Laboratories, Inc. | 07/21/1987SE |
| K871056 | Medicam S-4 Surgical CameraFWF · Traditional | M.P. Video, Inc. | 03/31/1987SE |
| K863598 | Video Camera SystemFWF · Traditional | American Edwards Laboratories | 10/02/1986SE |
| K863376 | Model MC-1 Surgical Video CameraFWF · Traditional | Biometric Products, Inc. | 10/02/1986SE |
| K834069 | Arthroscan Video SystemFWF · Traditional | Concept, Inc. | 01/27/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0782-2007 | SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France…Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for… | Smith & Nephew, Inc Endoscopy Division | 01/19/2007Terminated |
| Z-0781-2007 | SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France…Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for… | Smith & Nephew, Inc Endoscopy Division | 01/19/2007Terminated |