Imagyn Falloposcopy System
FDA 510(k) K963580 · Imagyn Medical, Inc.
510(k) numberK963580
Submission
- Device name
- Imagyn Falloposcopy System
- Applicant
- Imagyn Medical, Inc.
Laguna Niguel, CA, US - Received
- September 6, 1996
- Decision date
- January 31, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MKO – Falloposcope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1690
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MKO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221965 | FemDx FalloViewMKO · Traditional | Femdx Medsystems, Inc. | 03/17/2023SE |
| K974028 | Stargate Falloposcopy Catheter, Trifurcated Irrigation TubingMKO · Traditional | Conceptus, Inc. | 01/21/1998SE |
| K962587 | Conceptus Fallopian Tube Catheteization with Microendoscopy SystemMKO · Traditional | Conceptus, Inc. | 01/31/1997SE |
More from Conceptus, 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 |
| 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 |
| K953201 | Imagyn UroscopeFAJ · Traditional | 08/02/1995SE |
Questions and answers
When was Imagyn Falloposcopy System cleared by the FDA?
Imagyn Falloposcopy System (K963580) received a 510(k) decision of Substantially Equivalent on January 31, 1997, 147 days after the submission was received.
What is the product code of K963580?
The FDA product code is MKO – Falloposcope, a Class II (moderate risk) device regulated under 21 CFR 884.1690.