Conceptus Fallopian Tube Catheterization System
FDA 510(k) K953314 · Conceptus, Inc.
510(k) numberK953314
Submission
- Device name
- Conceptus Fallopian Tube Catheterization System
- Applicant
- Conceptus, Inc.
San Carlos, CA, US - Received
- July 12, 1995
- Decision date
- July 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MOV – Catheters, Salpingography
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MOV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180552 | Modified Novy Cornual Cannulation SetMOV · Special | Cook Incorporated | 07/12/2018SE |
| K932436 | Echomark Intrauterine Guiding CatheterMOV · Traditional | Echocath, Inc. | 11/16/1995SE |
| K931534 | Ovamed Intrauterine Access CatheterMOV · Traditional | Ovamed Corp. | 07/28/1995SE |
| K931476 | Novy Cornual Cannulation SetMOV · Traditional | Cook Ob/Gyn | 07/28/1995SE |
More from Cook Ob/Gyn
| 510(k) | Device | Decision |
|---|---|---|
| K974028 | Stargate Falloposcopy Catheter, Trifurcated Irrigation TubingMKO · Traditional | 01/21/1998SE |
| K972210 | Resectoscope Safety SheathHIH · Traditional | 09/05/1997SE |
| K962587 | Conceptus Fallopian Tube Catheteization with Microendoscopy SystemMKO · Traditional | 01/31/1997SE |
| K954164 | HysteroscopeHIH · Traditional | 03/12/1996SE |
| 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 Catheterization System cleared by the FDA?
Conceptus Fallopian Tube Catheterization System (K953314) received a 510(k) decision of Substantially Equivalent on July 28, 1995, 16 days after the submission was received.
What is the product code of K953314?
The FDA product code is MOV – Catheters, Salpingography, a Class II (moderate risk) device regulated under 21 CFR 884.4530.