Cleared Traditional

Anthogyr INTEGRAL Guided Surgery Cassettes

K233264 · Anthogyr · General Hospital

Dec 2023

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K233264 is an FDA 510(k) clearance for the Anthogyr INTEGRAL Guided Surgery Cassettes, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Anthogyr (Sallanches, FR). The FDA issued a Cleared decision on December 22, 2023, 84 days after receiving the submission on September 29, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K233264 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2023
Decision Date	December 22, 2023
Days to Decision	84 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850