Cleared Traditional

Instrument kits

K160730 · Anthogyr · General Hospital

Apr 2017

Decision

407d

Days

Class 2

Risk

About This 510(k) Submission

K160730 is an FDA 510(k) clearance for the Instrument kits, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Anthogyr (Sallanches, FR). The FDA issued a Cleared decision on April 27, 2017, 407 days after receiving the submission on March 16, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K160730 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 2016
Decision Date	April 27, 2017
Days to Decision	407 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