Cleared Traditional

VereSee Optical Veres Needle System

K232464 · Freyja Healthcare, LLC · Obstetrics & Gynecology

May 2024

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K232464 is an FDA 510(k) clearance for the VereSee Optical Veres Needle System, a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by Freyja Healthcare, LLC (North Andover, US). The FDA issued a Cleared decision on May 2, 2024, 261 days after receiving the submission on August 15, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.

Submission Details

510(k) Number	K232464 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2023
Decision Date	May 02, 2024
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF