Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft— 510(k) K160869
Substantially EquivalentCook Biotech Incorporated
FDA 510(k) clearance K160869 for Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft, Substantially Equivalent on 2016-04-29. Applicant: Cook Biotech Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Biotech Incorporated
- 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
- West Lafayette, IN, US
Recent devices under product code FTM
view allMore clearances from Cook Biotech Incorporated
view all- K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
- K201000 — Biodesign Staple Line Reinforcement
- K191696 — Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
- K171817 — Biodesign Diaphragmatic Hernia Graft
- K162934 — Biodesign Parastomal Hernia Repair Graft
Adverse 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 K160869
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 K160869.
Data sourced from openFDA. This site is unofficial and independent of the FDA.