FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE
K Number: K111313
·
Decision Dec 14, 2011
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
52
Applicant Total
1
Review Days
218
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
- EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE
- K Number
- K111313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5475
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alcavis Hdc, LLC
- Date Received
- May 10, 2011
- Decision Date
- December 14, 2011
- Product Code
- FQH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FQH | Lavage, Jet | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FQH), ordered by most recent decision date.
BD Surgiphor Antimicrobial Irrigation System (910110)
FDA 510(k)
FDA Class 2
·General Hospital
BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)
FDA 510(k)
FDA Class 2
·General Hospital
ERBEJET® 2 System
FDA 510(k)
FDA Class 2
·General Hospital
Armis VeriCyn Wound Wash
FDA 510(k)
FDA Class 2
·General Hospital
VERSAJET Hydrosurgery System (III)
FDA 510(k)
FDA Class 2
·General Hospital
BD Surgiphor Antimicrobial Irrigation System
FDA 510(k)
FDA Class 2
·General Hospital