Trocar and Cannula Accessory
FDA 510(k) K945741 · Applied Medical Resources
510(k) numberK945741
Submission
- Device name
- Trocar and Cannula Accessory
- Applicant
- Applied Medical Resources
Launa Hills, CA, US - Received
- November 23, 1994
- Decision date
- February 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Trocar and Cannula Accessory cleared by the FDA?
Trocar and Cannula Accessory (K945741) received a 510(k) decision of Substantially Equivalent on February 28, 1995, 97 days after the submission was received.
What is the product code of K945741?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.