Gentrix Surgical Matrix
FDA 510(k) K162554 · Acell, Inc.
510(k) numberK162554
Submission
- Device name
- Gentrix Surgical Matrix
- Applicant
- Acell, Inc.
Columbia, MD, US - Received
- September 13, 2016
- Decision date
- October 21, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Gentrix Surgical Matrix cleared by the FDA?
Gentrix Surgical Matrix (K162554) received a 510(k) decision of Substantially Equivalent on October 21, 2016, 38 days after the submission was received.
What is the product code of K162554?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.