FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
K Number: K132891
·
Decision Jun 19, 2014
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
6
Review Days
276
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
- HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
- K Number
- K132891
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Hymed Group Corp.
- Date Received
- September 16, 2013
- Decision Date
- June 19, 2014
- Product Code
- FRO
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRO), ordered by most recent decision date.
Bonvadis®
FDA 510(k)
FDA Unclassified
·Unknown
StatSeal Disc
FDA 510(k)
FDA Unclassified
·Unknown
IWD-Gel
FDA 510(k)
FDA Unclassified
·Unknown
MiraChlor Antimicrobial Wound Solution
FDA 510(k)
FDA Unclassified
·Unknown
Promogran Prisma Collagen Matrix with ORC and Silver
FDA 510(k)
FDA Unclassified
·Unknown
LUOFUCON® Antimicrobial Wound Gel
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by The Hymed Group Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K061227 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER | Dec 20, 2006 | Substantially Equivalent |
| K994339 | HYCURE ORAL / HYCURE ORAL SMART GEL | Mar 22, 2000 | Substantially Equivalent |
| K961930 | CHONDROPROTEC | Oct 15, 1996 | Substantially Equivalent for Some Indications |
| K960686 | HYCOAT | Aug 12, 1996 | Substantially Equivalent for Some Indications |
| K955506 | HYCURE | Jan 17, 1996 | Substantially Equivalent |