Fortaflex Surgical Mesh
FDA 510(k) K011025 · Organogenesis, Inc.
510(k) numberK011025
Submission
- Device name
- Fortaflex Surgical Mesh
- Applicant
- Organogenesis, Inc.
Canton, MA, US - Received
- April 5, 2001
- Decision date
- August 24, 2001
- 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 Fortaflex Surgical Mesh cleared by the FDA?
Fortaflex Surgical Mesh (K011025) received a 510(k) decision of Substantially Equivalent on August 24, 2001, 141 days after the submission was received.
What is the product code of K011025?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.