Myoma Drill 5MM-8383.611
FDA 510(k) K940844 · Richard Wolf Medical Instruments Corp.
510(k) numberK940844
Submission
- Device name
- Myoma Drill 5MM-8383.611
- Applicant
- Richard Wolf Medical Instruments Corp.
Vernon Hills, IL, US - Received
- February 23, 1994
- Decision date
- May 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Myoma Drill 5MM-8383.611 cleared by the FDA?
Myoma Drill 5MM-8383.611 (K940844) received a 510(k) decision of Substantially Equivalent on May 2, 1994, 68 days after the submission was received.
What is the product code of K940844?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.