Biodesign Staple Line Reinforcement— 510(k) K170945
Substantially EquivalentCook Biotech Incorporated
FDA 510(k) clearance K170945 for Biodesign Staple Line Reinforcement, Substantially Equivalent on 2017-04-28. Applicant: Cook Biotech Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Biotech Incorporated
- Product code
- Code OXE
- 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 OXE
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.