510(k) DEN080011
DEN080011 is an FDA 510(k) premarket notification submitted by Spiracur, Inc. for the device "SNAP WOUND CARE DEVICE". The FDA issued a decision of De Novo Granted on August 7, 2009. The device falls under product code OKO (Negative Pressure Wound Therapy Non-Powered Suction Apparatus), a Class II device regulated under 21 CFR 878.4683. Spiracur, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 7, 2009
- Date Received
- November 3, 2008
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Negative Pressure Wound Therapy Non-Powered Suction Apparatus
- Device Class
- Class II
- Regulation Number
- 878.4683
- Review Panel
- SU
- Submission Type
A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.