SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction— 510(k) K162965
Substantially EquivalentTei Biosciences, Inc.
FDA 510(k) clearance K162965 for SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction, Substantially Equivalent on 2017-02-16. Applicant: Tei Biosciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Tei Biosciences, Inc.
- Product code
- Code FTM
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code FTM
view allMore clearances from Tei Biosciences, Inc.
view allAdverse events under product code FTM
product code FTM- Death
- 17
- Injury
- 2,174
- Total
- 2,191
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K162965
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162965.
Data sourced from openFDA. This site is unofficial and independent of the FDA.