FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Cook ECM Powder
K Number: K152033
·
Decision Aug 19, 2015
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
16
Review Days
28
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Basic Information
- Device Name
- Cook ECM Powder
- K Number
- K152033
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Biotech Incorporated
- Date Received
- July 22, 2015
- Decision Date
- August 19, 2015
- Product Code
- KGN
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
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Other Clearances by Cook Biotech Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | May 24, 2024 | Substantially Equivalent |
| K201000 | Biodesign Staple Line Reinforcement | Jul 13, 2020 | Substantially Equivalent |
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft | Dec 27, 2019 | Substantially Equivalent |
| K171817 | Biodesign Diaphragmatic Hernia Graft | Mar 13, 2018 | Substantially Equivalent |
| K162934 | Biodesign Parastomal Hernia Repair Graft | Jul 10, 2017 | Substantially Equivalent |
| K170016 | Biodesign Fistula Plug | Jun 21, 2017 | Substantially Equivalent |
| K170945 | Biodesign Staple Line Reinforcement | Apr 28, 2017 | Substantially Equivalent |
| K161762 | DynaMatrix/Dynamatrix Plus | Jan 13, 2017 | Substantially Equivalent |
| K162741 | AxoGuard Nerve Connector | Oct 31, 2016 | Substantially Equivalent |
| K160136 | Flowable Wound Matrix | Sep 28, 2016 | Substantially Equivalent |