Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
FDA 510(k) K141084 · Acell, Inc.
510(k) numberK141084
Submission
- Device name
- Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
- Applicant
- Acell, Inc.
Columbia, MD, US - Received
- April 28, 2014
- Decision date
- June 17, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix cleared by the FDA?
Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix (K141084) received a 510(k) decision of Substantially Equivalent on June 17, 2015, 415 days after the submission was received.
What is the product code of K141084?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.