Cleared Traditional

iTotal Family Reusable Instrument Tray

K170226 · Conformis, Inc. · General Hospital

Oct 2017

Decision

273d

Days

Class 2

Risk

About This 510(k) Submission

K170226 is an FDA 510(k) clearance for the iTotal Family Reusable Instrument Tray, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Conformis, Inc. (Bedford, US). The FDA issued a Cleared decision on October 25, 2017, 273 days after receiving the submission on January 25, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K170226 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 2017
Decision Date	October 25, 2017
Days to Decision	273 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