Imagyn Medical Videoscopy Syst W/Irrig Pump/Access
FDA 510(k) K911163 · Imagyn Medical, Inc.
510(k) numberK911163
Submission
- Device name
- Imagyn Medical Videoscopy Syst W/Irrig Pump/Access
- Applicant
- Imagyn Medical, Inc.
San Clemente, CA, US - Received
- March 15, 1991
- Decision date
- June 3, 1991
- 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 |
|---|---|---|
| K972426 | Microspan Gold Hysteroscope and Microspan Hysteroscope SheathHIH · Traditional | 09/23/1997SE |
| K970750 | Microspan Insemination SystemMFD · Traditional | 05/05/1997SE |
| K971255 | Imagyn Expandable Laparoscopic IntroducerHET · Traditional | 04/21/1997SE |
| K965055 | Imagyn Microlap and Micro Lap-Gold LaparoscopesHET · Traditional | 03/06/1997SE |
| K963580 | Imagyn Falloposcopy SystemMKO · Traditional | 01/31/1997SE |
| K961688 | Microspan HysteroscopeHIH · Traditional | 10/15/1996SE |
| K961506 | Microspan Hysteroscope SheathHIH · Traditional | 07/03/1996SE |
| K952032 | Imagyn Hysteroscope SheathsHIH · Traditional | 10/31/1995SE |
| K951996 | Imagyn EndoscopeGCJ · Traditional | 09/01/1995SE |
| K951974 | Imagyn Endoscope SheathGCJ · Traditional | 08/28/1995SE |
Questions and answers
When was Imagyn Medical Videoscopy Syst W/Irrig Pump/Access cleared by the FDA?
Imagyn Medical Videoscopy Syst W/Irrig Pump/Access (K911163) received a 510(k) decision of Substantially Equivalent on June 3, 1991, 80 days after the submission was received.
What is the product code of K911163?
The FDA product code is FWF – Camera, Television, Endoscopic, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.