510(k) K232464
K232464 is an FDA 510(k) premarket notification submitted by Freyja Healthcare, LLC for the device "VereSee Optical Veres Needle System". The FDA issued a decision of Substantially Equivalent on May 2, 2024. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Freyja Healthcare, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2024
- Date Received
- August 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