ENDOFORM DERMAL TEMPLATE— 510(k) K092096
Substantially EquivalentMesynthes, Ltd.
FDA 510(k) clearance K092096 for ENDOFORM DERMAL TEMPLATE, Substantially Equivalent on 2010-01-21. Applicant: Mesynthes, Ltd.. Device class: Unclassified.
Clearance details
- Applicant
- Mesynthes, Ltd.
- Product code
- Code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code KGN
view allMore clearances from Mesynthes, Ltd.
view allAdverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
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 K092096
K-number listed on FDA's recall record- Z-0377-2019 — Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
- Z-0378-2019 — Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
- Z-0379-2019 — Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092096.
Data sourced from openFDA. This site is unofficial and independent of the FDA.