Medicam S-4 Surgical Camera
FDA 510(k) K871056 · M.P. Video, Inc.
510(k) numberK871056
Submission
- Device name
- Medicam S-4 Surgical Camera
- Applicant
- M.P. Video, Inc.
North Attleboro, MA, US - Received
- March 17, 1987
- Decision date
- March 31, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FWF – Camera, Television, Endoscopic, Without Audio
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FWF
| 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 |
More from Medical Dynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951386 | Combination Camera/Light SourceGCJ · Traditional | 06/30/1995SE |
| K943342 | Medicam Xenon Light SourceFSW · Traditional | 10/17/1994SE |
| K942358 | Autoclaveable Medicam 900 Digicon CameraGCJ · Traditional | 08/08/1994SE |
| K941773 | Medicam 900 RemoteGCJ · Traditional | 07/18/1994SE |
| K941693 | Medicam Endocoupler and BeamsplitterGCJ · Traditional | 06/27/1994SE |
| K893828 | ML-800 Autoelectronic Light SourceFST · Traditional | 07/24/1989SE |
| K882924 | Medicam MC-7 and RP-7 Surgical CamerasKQM · Traditional | 07/26/1988SE |
| K871595 | Surgical Camera AccessoriesKQM · Traditional | 05/07/1987SE |
| K871057 | Mc-Series Surgical CamerasFWB · Traditional | 04/03/1987SE |
| K820829 | MedicamFWB · Traditional | 05/03/1982SE |
Questions and answers
When was Medicam S-4 Surgical Camera cleared by the FDA?
Medicam S-4 Surgical Camera (K871056) received a 510(k) decision of Substantially Equivalent on March 31, 1987, 14 days after the submission was received.
What is the product code of K871056?
The FDA product code is FWF – Camera, Television, Endoscopic, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.