Cook ECM Powder— 510(k) K152033
Substantially EquivalentCook Biotech Incorporated
FDA 510(k) clearance K152033 for Cook ECM Powder, Substantially Equivalent on 2015-08-19. Applicant: Cook Biotech Incorporated. Device class: Unclassified.
Clearance details
- Applicant
- Cook Biotech Incorporated
- Product code
- Code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- West Lafayette, IN, US
Recent devices under product code KGN
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 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.