Intrauterine Delivery System - Injector
FDA 510(k) K023051 · Prosurg, Inc.
510(k) numberK023051
Submission
- Device name
- Intrauterine Delivery System - Injector
- Applicant
- Prosurg, Inc.
San Jose, CA, US - Received
- September 13, 2002
- Decision date
- December 12, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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Questions and answers
When was Intrauterine Delivery System - Injector cleared by the FDA?
Intrauterine Delivery System - Injector (K023051) received a 510(k) decision of Substantially Equivalent on December 12, 2002, 90 days after the submission was received.
What is the product code of K023051?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.