Cleared Traditional

K223672 - Instrument Case P1340904
(FDA 510(k) Clearance)

K223672 · Cochlear · General Hospital

Mar 2023

Decision

104d

Days

Class 2

Risk

K223672 is an FDA 510(k) clearance for the Instrument Case P1340904, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Cochlear (Centennial, US). The FDA issued a Cleared decision on March 21, 2023, 104 days after receiving the submission on December 7, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K223672 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 07, 2022
Decision Date	March 21, 2023
Days to Decision	104 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