Morcellex Sigma Generator
FDA 510(k) K131656 · ETHICON, Inc.
510(k) numberK131656
Submission
- Device name
- Morcellex Sigma Generator
- Applicant
- ETHICON, Inc.
Somerville, NJ, US - Received
- June 6, 2013
- Decision date
- September 27, 2013
- 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 Morcellex Sigma Generator cleared by the FDA?
Morcellex Sigma Generator (K131656) received a 510(k) decision of Substantially Equivalent on September 27, 2013, 113 days after the submission was received.
What is the product code of K131656?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.