Lyograft
FDA 510(k) K192452 · B. Bruan Surgical, SA
510(k) numberK192452
Submission
- Device name
- Lyograft
- Applicant
- B. Bruan Surgical, SA
Rubi, ES - Received
- September 9, 2019
- Decision date
- September 3, 2020
- 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 Lyograft cleared by the FDA?
Lyograft (K192452) received a 510(k) decision of Substantially Equivalent on September 3, 2020, 360 days after the submission was received.
What is the product code of K192452?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.