Applied Laparoscopic Monopolar Scissors
FDA 510(k) K040295 · Applied Medical Resources Corp.
510(k) numberK040295
Submission
- Device name
- Applied Laparoscopic Monopolar Scissors
- Applicant
- Applied Medical Resources Corp.
Rancho Santa, CA, US - Received
- February 9, 2004
- Decision date
- March 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Applied Laparoscopic Monopolar Scissors cleared by the FDA?
Applied Laparoscopic Monopolar Scissors (K040295) received a 510(k) decision of Substantially Equivalent on March 12, 2004, 32 days after the submission was received.
What is the product code of K040295?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.