Inpath E2 Collector

FDA 510(k) K013258 · Molecular Diagnostics

Substantially Equivalent

510(k) numberK013258

Submission

Device name
Inpath E2 Collector
Applicant
Molecular Diagnostics
Chicago, IL, US
Received
October 1, 2001
Decision date
May 31, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HHT – Spatula, Cervical, Cytological
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

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K141057Disposable Cervical BrushHHT · Traditional Ningbo Hls Medical Products Co., Ltd.05/14/2015SE
K111681HistobrushHHT · Traditional Puritan Medical Products Company, LLC01/19/2012SE
K083012PapconeHHT · Traditional Otto Bock Pur Life Science GmbH04/09/2009SE
K081522Bio Nuclear Diagnostics (Endo)Cervical Sampler for Gyn CytologyHHT · Traditional Bio Nuclear Diagnostics, Inc.12/05/2008SE
K072381Softpap Cervical Cell CollectorHHT · Special Cytocore, Inc.01/30/2008SE
K062433Diamics Cercol Cervical Sample Collector SystemHHT · Traditional Diamics, Inc.03/16/2007SE
K043369Cervex-Brush CombiHHT · Traditional Rovers Medical Devices B.V.02/02/2005SE
K042527Spatula, Cervical, Cytological, Model 22-9107HHT · Traditional Medical Action Industries, Inc.11/08/2004SE

Questions and answers

When was Inpath E2 Collector cleared by the FDA?

Inpath E2 Collector (K013258) received a 510(k) decision of Substantially Equivalent on May 31, 2002, 242 days after the submission was received.

What is the product code of K013258?

The FDA product code is HHT – Spatula, Cervical, Cytological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.