Cleared Traditional

Perforated Baskets

K231291 · Richard Wolf Medical Instruments Corporation · General Hospital

Jun 2024

Decision

396d

Days

Class 2

Risk

About This 510(k) Submission

K231291 is an FDA 510(k) clearance for the Perforated Baskets, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Richard Wolf Medical Instruments Corporation (Vernon Hills, US). The FDA issued a Cleared decision on June 3, 2024, 396 days after receiving the submission on May 4, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K231291 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2023
Decision Date	June 03, 2024
Days to Decision	396 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