510(k) K202279
K202279 is an FDA 510(k) premarket notification submitted by Innovative Health Sciences, LLC for the device "Insignis Subcutaneous Needle Sets". The FDA issued a decision of Substantially Equivalent on Aug 13, 2021. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Innovative Health Sciences, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 2021
- Date Received
- Aug 11, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type