510(k) K212971
K212971 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 February 10, 2022. 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
- February 10, 2022
- Date Received
- September 17, 2021
- Clearance Type
- Traditional
- 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.