Surgical Video Camera and Accessories
FDA 510(k) K934682 · Medical Dynamics, Inc.
510(k) numberK934682
Submission
- Device name
- Surgical Video Camera and Accessories
- Applicant
- Medical Dynamics, Inc.
Englewood, CO, US - Received
- September 30, 1993
- Decision date
- February 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K932628 | Endoscopic Video CameraFWF · Traditional | Stephen Chakoff, Inc. | 10/15/1993SE |
More from Stephen Chakoff, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K974542 | True Vision, True Vision IIEIA · Traditional | 02/17/1998SE |
| K921294 | Video Endoscope-Rigid ModificationHET · Traditional | 07/20/1994SE |
| K930568 | Adair/Veress Needle Introducer SetGCB · Traditional | 07/22/1993SE |
| K915538 | Over the Wire Stone BasketLQR · Traditional | 03/20/1992SE |
| K914315 | Optical Catheter Introducer Sets, ModificationKGX · Traditional | 03/04/1992SE |
| K913986 | Cholangiography/Cholangioscopy/Lihopaxy SystemFGE · Traditional | 01/28/1992SESK |
| K911296 | Optical Catheter ArthroscopeHRX · Traditional | 09/24/1991SE |
| K903339 | Video Endoscope, RigidHET · Traditional | 03/06/1991SE |
| K904609 | Xenon Light SourceHBI · Traditional | 12/18/1990SE |
| K904113 | Operative Recording CameraIKO · Traditional | 10/30/1990SE |
Questions and answers
When was Surgical Video Camera and Accessories cleared by the FDA?
Surgical Video Camera and Accessories (K934682) received a 510(k) decision of Substantially Equivalent on February 15, 1994, 138 days after the submission was received.
What is the product code of K934682?
The FDA product code is FWF – Camera, Television, Endoscopic, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.