Cleared Traditional

Anthogyr Surgical Cassettes

K230680 · Anthogyr · General Hospital

Jul 2023

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K230680 is an FDA 510(k) clearance for the Anthogyr Surgical 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 July 11, 2023, 120 days after receiving the submission on March 13, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K230680 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2023
Decision Date	July 11, 2023
Days to Decision	120 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