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Sign in to claim this brandCOOK BIOTECH INCORPORATED
United States·US-MF-000001990
Last updated May 27, 2026
What COOK BIOTECH INCORPORATED makes
Cook Biotech Incorporated manufactures bioabsorbable surgical meshes for extra-gynaecological applications, including collagen-based implants designed for tissue integration. The company also produces animal-derived biomaterials for wound care, such as wound matrix dressings and shields, as well as nerve guides and tissue biomatrix implants for ENT and dura mater applications. Additional products include fistula-repair biomatrix implants for targeted tissue regeneration.
The company’s portfolio spans Class I, Class II, Class III, and unclassified devices, with registrations in the EU’s eudamed database, FDA’s 510(k) clearance records, and FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Cook Biotech Incorporated manufacture?
Cook Biotech Incorporated specializes in bioabsorbable and animal-derived medical devices. Their portfolio includes extra-gynaecological surgical meshes made from collagen, designed for tissue integration. They also produce wound care products like animal-derived wound matrix dressings and wound shields, as well as nerve guides and tissue biomatrix implants for ear, nose, and throat (ENT) applications and dura mater repairs. Additionally, they offer fistula-repair biomatrix implants for targeted tissue regeneration.
Where is Cook Biotech Incorporated based?
Cook Biotech Incorporated is headquartered in the United States. The company’s location is relevant for regulatory inquiries, as it operates under U.S. regulatory frameworks like the FDA’s 510(k) clearance and UDI systems.
Which regulatory registries list devices manufactured by Cook Biotech Incorporated?
Devices from Cook Biotech Incorporated are listed in multiple global regulatory databases. Their products appear in the EU’s eudamed registry, the FDA’s 510(k) clearance records, and the FDA’s Unique Device Identifier (UDI) system. These registries help track device authorizations and compliance across markets.
How are Cook Biotech Incorporated’s devices classified under regulatory frameworks?
Cook Biotech Incorporated’s devices span multiple regulatory classes depending on their intended use and risk level. Their portfolio includes Class I (low-risk), Class II (moderate-risk), Class III (high-risk, often requiring premarket approval), and unclassified devices. Classification determines the regulatory pathway, such as FDA’s 510(k) or PMA processes, ensuring appropriate oversight based on device risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 1425, Innovation Place, West Lafayette, United States
- Website
- evergenbio.com
- —
- —
- [email protected]
- Phone
- +1(812)330-5494
- PRRC Contact
- Monica Bravo
- EUDAMED SRN
- US-MF-000001990
- FDA FEI Number
- —
- DUNS Number
- 945385862
Catalogue (235)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HaloShield | G46290 | FDA UDI | Class I | Active |
| Oasis | G57608 | FDA UDI | U | Active |
| DynaMatrix Plus | G56902 | FDA UDI | Class II | Active |
| Biodesign | G23662 | FDA UDI | Class II | Unknown |
| Biodesign | G31141 | FDA UDI | Class II | Unknown |
| Biodesign | G54200 | FDA UDI | Class II | Active |
| Biodesign | G44840 | FDA UDI | Class II | Active |
| HaloShield | G46289 | FDA UDI | Class I | Active |
| Biodesign Additae | G59287 | FDA UDI | Class II | Unknown |
| AxoGuard Nerve Connector | AGX110-2 | EUDAMED | Class III | Active |
| Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft | K191696 | FDA 510(k) | Class II | Active |
| Biodesign Staple Line Reinforcement | K201000 | FDA 510(k) | Class II | Active |
| Biodesign Enterocutaneous Fistula Plug | K150668 | FDA 510(k) | Class II | Active |
| Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | K161221 | FDA 510(k) | Class II | Active |
| Biodesign Parastomal Hernia Repair Graft | K162934 | FDA 510(k) | Class II | Active |
| Nerve Cuff | K132660 | FDA 510(k) | Class II | Active |
| Biodesign Fistula Plug | K170016 | FDA 510(k) | Class II | Active |
| Biodesign Otologic Repair Graft | K161000 | FDA 510(k) | Class II | Active |
| Biodesign Otologic Repair Graft | K150594 | FDA 510(k) | Class II | Active |
| Biodesign Diaphragmatic Hernia Graft | K171817 | FDA 510(k) | Class II | Active |
| Flowable Wound Matrix | K160136 | FDA 510(k) | U | Active |
| Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | K232646 | FDA 510(k) | Class II | Active |
| Cook ECM Powder | K152033 | FDA 510(k) | U | Active |
| Biodesign Staple Line Reinforcement | K170945 | FDA 510(k) | Class II | Active |
| Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts | K130006 | FDA 510(k) | Class III | Active |
| Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft | K160869 | FDA 510(k) | Class II | Active |
| SIS Inguinal Hernia Repair Graft | K142887 | FDA 510(k) | Class II | Active |
| DynaMatrix/Dynamatrix Plus | K161762 | FDA 510(k) | Class II | Active |
| Biodesign Ent Repair Graft | K121360 | FDA 510(k) | Class II | Active |
| AxoGuard Nerve Connector | AGX415-2 | EUDAMED | Class III | Active |
| Biodesign Hernia Graft | C-SLH-8H-13X22-2 | EUDAMED | Class III | Active |
| AxoGuard Nerve Connector | AGX210-2 | EUDAMED | Class III | Active |
| Biodesign Hernia Graft | C-SLH-8H-20X20-2 | EUDAMED | Class III | Active |
| AxoGuard Nerve Connector | AGX410-2 | EUDAMED | Class III | Active |
| AxoGuard Nerve Connector | AGX215-2 | EUDAMED | Class III | Active |
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