Cleared Traditional

TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS

K112087 · Advanced Sterilization Products · General Hospital

Oct 2012

Decision

452d

Days

Class 2

Risk

About This 510(k) Submission

K112087 is an FDA 510(k) clearance for the TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on October 15, 2012, 452 days after receiving the submission on July 21, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K112087 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 2011
Decision Date	October 15, 2012
Days to Decision	452 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