BIOMONDE LARVAE
FDA 510(k) clearance K123449 · decided 2013-03-05
Clearance details
- K-number
- K123449
- Device name
- BIOMONDE LARVAE
- Applicant
- Biomonde (A Trading Name of Zoobiotic Limited)
- Decision
- Substantially Equivalent
- Date received
- 2012-11-09
- Decision date
- 2013-03-05
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- NQK
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Southbrough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 (K142020) | Biomonde | 2014-11-05 |
| LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 (K131221) | Biomonde | 2013-08-28 |
| MEDICAL MAGGOTS, LESOC (K102827) | Monarch Labs, LLC | 2011-11-02 |
| MEDICAL MAGGOTS, CREATURE COMFORTS (K072438) | Monarch Labs, LLC | 2007-10-05 |
| MEDICAL MAGGOTS (K033391) | Ronald A. Sherman | 2004-01-12 |
Recalls involving this device
No recalls on record reference this clearance.