Cleared Traditional

exCellerator Cervical Collection Device

K182049 · Excell Company, LLC · Pathology

Apr 2019

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K182049 is an FDA 510(k) clearance for the exCellerator Cervical Collection Device, a Spatula, Cervical, Cytological (Class II — Special Controls, product code HHT), submitted by Excell Company, LLC (Carmel, US). The FDA issued a Cleared decision on April 25, 2019, 268 days after receiving the submission on July 31, 2018. This device falls under the Pathology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K182049 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2018
Decision Date	April 25, 2019
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF