Endoscopic Video Camera
FDA 510(k) K932628 · Stephen Chakoff, Inc.
510(k) numberK932628
Submission
- Device name
- Endoscopic Video Camera
- Applicant
- Stephen Chakoff, Inc.
Miami, FL, US - Received
- June 1, 1993
- Decision date
- October 15, 1993
- 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 |
| K934682 | Surgical Video Camera and AccessoriesFWF · Traditional | Medical Dynamics, Inc. | 02/15/1994SE |
More from Medical Dynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940316 | HysterscopeHIH · Traditional | 11/16/1995SE |
| K940317 | SinuscopeEOB · Traditional | 05/24/1995SE |
| K950753 | Chakoff Endoscopy (Camera Television Endoscopic Without AudioGCJ · Traditional | 05/15/1995SE |
| K951082 | Chakoff Endoscopy, Rigid EndoscopeGCJ · Traditional | 03/22/1995SE |
| K950748 | Chakoff Endoscopy (Fiber Optic Light Source Routine)GCJ · Traditional | 03/06/1995SE |
| K950747 | Chakoff Endoscopy (Light Source Endoscopic Xenon Arc.)GCJ · Traditional | 03/06/1995SE |
| K950746 | Chakoff Endoscopy (Set Laparoscopy)GCJ · Traditional | 03/06/1995SE |
| K950745 | Chakoff Endoscopy (Endoscope And/Or Accessories)GCJ · Traditional | 03/06/1995SE |
| K950744 | Chakoff Endoscopy (Ridgid Endoscope)GCJ · Traditional | 03/06/1995SE |
| K945421 | Chakoff EndoscopyFDG · Traditional | 12/23/1994SE |
Questions and answers
When was Endoscopic Video Camera cleared by the FDA?
Endoscopic Video Camera (K932628) received a 510(k) decision of Substantially Equivalent on October 15, 1993, 136 days after the submission was received.
What is the product code of K932628?
The FDA product code is FWF – Camera, Television, Endoscopic, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.