FDA 510(k)
FDA unclassified
Substantially Equivalent
🇯🇵 Japan
PELNAC Bilayer Wound Matrix
K Number: K191992
·
Decision Apr 29, 2020
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
5
Review Days
279
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PELNAC Bilayer Wound Matrix
- K Number
- K191992
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gunze Limited
- Date Received
- July 25, 2019
- Decision Date
- April 29, 2020
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGN), ordered by most recent decision date.
ECMT-100 WMD
FDA 510(k)
FDA Unclassified
·Unknown
Catalyze
FDA 510(k)
FDA Unclassified
·Unknown
Roosin Collagen Dressing
FDA 510(k)
FDA Unclassified
·Unknown
Roosin Collagen Powder
FDA 510(k)
FDA Unclassified
·Unknown
MatriDerm
FDA 510(k)
FDA Unclassified
·Unknown
Derma-Gide
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Gunze Limited
| K Number | Device Name | ||
|---|---|---|---|
| K221487 | NEOVEIL Staple Line Reinforcement | Aug 26, 2022 | Substantially Equivalent |
| K213498 | PELNAC Meshed Bilayer Wound Matrix | Jul 14, 2022 | Substantially Equivalent |
| K213573 | PELNAC Wound Matrix | Feb 9, 2022 | Substantially Equivalent |
| K130997 | NEOVEIL | Nov 15, 2013 | Substantially Equivalent |