Avance Abdominal Dressing Kit
FDA 510(k) clearance K161939 · decided 2016-11-17
Clearance details
- K-number
- K161939
- Device name
- Avance Abdominal Dressing Kit
- Applicant
- Molnlycke Health Care Us, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-07-14
- Decision date
- 2016-11-17
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- OXJ
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Norcross, GA, 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 |
|---|---|---|
| AVANCE® FOAM ABDOMINAL DRESSING KIT (K130852) | Molnlycke Health Care | 2014-04-14 |
Recalls involving this device
No recalls on record reference this clearance.