FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400
K Number: K131221
·
Decision Aug 28, 2013
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
2
Review Days
120
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Basic Information
- Device Name
- LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400
- K Number
- K131221
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomonde
- Date Received
- April 30, 2013
- Decision Date
- August 28, 2013
- Product Code
- NQK
- 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 |
|---|---|---|---|
| NQK | Maggots, Medical | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NQK), ordered by most recent decision date.
LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400
FDA 510(k)
FDA Unclassified
·Unknown
BIOMONDE LARVAE
FDA 510(k)
FDA Unclassified
·Unknown
MEDICAL MAGGOTS, LESOC
FDA 510(k)
FDA Unclassified
·Unknown
MEDICAL MAGGOTS, CREATURE COMFORTS
FDA 510(k)
FDA Unclassified
·Unknown
MEDICAL MAGGOTS
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Biomonde
| K Number | Device Name | ||
|---|---|---|---|
| K142020 | LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 | Nov 5, 2014 | Substantially Equivalent |