SURGIMEND— 510(k) K083898
Substantially EquivalentTei Biosciences, Inc.
FDA 510(k) clearance K083898 for SURGIMEND, Substantially Equivalent on 2009-02-04. 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
- Special
- 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 K083898
K-number listed on FDA's recall record- Z-2072-2023 — SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,
- Z-2074-2023 — SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.
- Z-2075-2023 — SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083898.
Data sourced from openFDA. This site is unofficial and independent of the FDA.