Cleared Traditional

Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator

K163598 · Advanced Sterilization Products · General Hospital

Jul 2017

Decision

222d

Days

Class 2

Risk

About This 510(k) Submission

K163598 is an FDA 510(k) clearance for the Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Advanced Sterilization Products (Irvine, US). The FDA issued a Cleared decision on July 31, 2017, 222 days after receiving the submission on December 21, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K163598 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2016
Decision Date	July 31, 2017
Days to Decision	222 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