Echomark Intrauterine Guiding Catheter
FDA 510(k) K932436 · Echocath, Inc.
510(k) numberK932436
Submission
- Device name
- Echomark Intrauterine Guiding Catheter
- Applicant
- Echocath, Inc.
Princeton, NJ, US - Received
- May 19, 1993
- Decision date
- November 16, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K953314 | Conceptus Fallopian Tube Catheterization SystemMOV · Traditional | Conceptus, Inc. | 07/28/1995SE |
| K931534 | Ovamed Intrauterine Access CatheterMOV · Traditional | Ovamed Corp. | 07/28/1995SE |
| K931476 | Novy Cornual Cannulation SetMOV · Traditional | Cook Ob/Gyn | 07/28/1995SE |
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| K933417 | Echomark(R) Electrophysiology CatheterDRF · Traditional | 05/04/1995SE |
| K926351 | Colormark(Tm) Visualization SystemIYN · Traditional | 09/16/1993SE |
| K922787 | Echomark Guidewire with Ultrasonic LocalizationDQX · Traditional | 01/06/1993SE |
Questions and answers
When was Echomark Intrauterine Guiding Catheter cleared by the FDA?
Echomark Intrauterine Guiding Catheter (K932436) received a 510(k) decision of Substantially Equivalent on November 16, 1995, 911 days after the submission was received.
What is the product code of K932436?
The FDA product code is MOV – Catheters, Salpingography, a Class II (moderate risk) device regulated under 21 CFR 884.4530.