PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD— 510(k) K100261
Substantially EquivalentTei Biosciences, Inc.
FDA 510(k) clearance K100261 for PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD, Substantially Equivalent on 2010-12-10. Applicant: Tei Biosciences, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Tei Biosciences, Inc.
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Boston, MA, US
Recent devices under product code FRO
view allMore clearances from Tei Biosciences, Inc.
view allAdverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
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 K100261
K-number listed on FDA's recall record- Z-2080-2023 — PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
- Z-2081-2023 — PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
- Z-2082-2023 — PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100261.
Data sourced from openFDA. This site is unofficial and independent of the FDA.