510(k) K211130
K211130 is an FDA 510(k) premarket notification submitted by Guard Medical, Inc. for the device "NPseal". The FDA issued a decision of Substantially Equivalent on May 14, 2021. 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. Guard Medical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2021
- Date Received
- April 16, 2021
- Clearance Type
- Special
- 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.