510(k) K231407
K231407 is an FDA 510(k) premarket notification submitted by Premium Medical Technology, LLC for the device "StarFin". The FDA issued a decision of Substantially Equivalent on August 29, 2023. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2023
- Date Received
- May 15, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Laparoscopic
- Device Class
- Class II
- Regulation Number
- 884.1730
- Review Panel
- OB
- Submission Type