Uterine Manipulator Injector Cannula, Model R57-450
FDA 510(k) K010296 · Marina Medical Instruments, Inc.
510(k) numberK010296
Submission
- Device name
- Uterine Manipulator Injector Cannula, Model R57-450
- Applicant
- Marina Medical Instruments, Inc.
Hollywood, FL, US - Received
- January 31, 2001
- Decision date
- April 11, 2001
- 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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Questions and answers
When was Uterine Manipulator Injector Cannula, Model R57-450 cleared by the FDA?
Uterine Manipulator Injector Cannula, Model R57-450 (K010296) received a 510(k) decision of Substantially Equivalent on April 11, 2001, 70 days after the submission was received.
What is the product code of K010296?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.