510(k) K232464

VereSee Optical Veres Needle System by Freyja Healthcare, LLC — Product Code HIF

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