Wallace Artificial Insemination Catheter
FDA 510(k) K061679 · Irvine Scientific Sales Co., Inc.
510(k) numberK061679
Submission
- Device name
- Wallace Artificial Insemination Catheter
- Applicant
- Irvine Scientific Sales Co., Inc.
Santa Ana, CA, US - Received
- June 15, 2006
- Decision date
- October 13, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKF – Cannula, Manipulator/Injector, Uterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography CatheterLKF · Traditional | Cook Incorporated | 03/29/2019SE |
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Questions and answers
When was Wallace Artificial Insemination Catheter cleared by the FDA?
Wallace Artificial Insemination Catheter (K061679) received a 510(k) decision of Substantially Equivalent on October 13, 2006, 120 days after the submission was received.
What is the product code of K061679?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.