510(k) K241522
K241522 is an FDA 510(k) premarket notification submitted by Guard Medical, Inc. for the device "NPseal (20 and 25)". The FDA issued a decision of Substantially Equivalent on August 15, 2024. 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
- August 15, 2024
- Date Received
- May 29, 2024
- 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.