Conceptus Fallopian Tube Catheteization with Microendoscopy System
FDA 510(k) K962587 · Conceptus, Inc.
510(k) numberK962587
Submission
- Device name
- Conceptus Fallopian Tube Catheteization with Microendoscopy System
- Applicant
- Conceptus, Inc.
San Carlos, CA, US - Received
- July 1, 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 |
| K963580 | Imagyn Falloposcopy SystemMKO · Traditional | Imagyn Medical, Inc. | 01/31/1997SE |
More from Imagyn Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K974028 | Stargate Falloposcopy Catheter, Trifurcated Irrigation TubingMKO · Traditional | 01/21/1998SE |
| K972210 | Resectoscope Safety SheathHIH · Traditional | 09/05/1997SE |
| K954164 | HysteroscopeHIH · Traditional | 03/12/1996SE |
| K953314 | Conceptus Fallopian Tube Catheterization SystemMOV · Traditional | 07/28/1995SE |
| K932387 | Conceptus Vari-Soft Cath/Pirouette Posit MandrelHET · Traditional | 03/06/1995SE |
| K932993 | Intrauterine Catheter and IntroducerMFD · Traditional | 01/06/1995SE |
| K933981 | Cervical CatheterLKF · Traditional | 12/27/1994SE |
| K933723 | Conceptus Uterine CatheterLKF · Traditional | 12/27/1994SE |
Questions and answers
When was Conceptus Fallopian Tube Catheteization with Microendoscopy System cleared by the FDA?
Conceptus Fallopian Tube Catheteization with Microendoscopy System (K962587) received a 510(k) decision of Substantially Equivalent on January 31, 1997, 214 days after the submission was received.
What is the product code of K962587?
The FDA product code is MKO – Falloposcope, a Class II (moderate risk) device regulated under 21 CFR 884.1690.