Harwill Medical Cervitula Cervical Spatula

Q: What is the product code of K983202?

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

FDA 510(k) K983202 · Harwill Medical (Pty) , Ltd.

Substantially Equivalent

510(k) numberK983202

Submission

Device name: Harwill Medical Cervitula Cervical Spatula
Applicant: Harwill Medical (Pty) , Ltd.
Crofton, MD, US
Received: September 14, 1998
Decision date: March 15, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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

Other 510(k)s with product code HHT

510(k)	Device	Applicant	Decision
K182049	exCellerator Cervical Collection DeviceHHT · Traditional	Excell Company, LLC	04/25/2019SE
K153128	Kolplast Cervical Sample Collection KitHHT · Traditional	Kolplast CI SA	01/13/2017SE
K141057	Disposable Cervical BrushHHT · Traditional	Ningbo Hls Medical Products Co., Ltd.	05/14/2015SE
K111681	HistobrushHHT · Traditional	Puritan Medical Products Company, LLC	01/19/2012SE
K083012	PapconeHHT · Traditional	Otto Bock Pur Life Science GmbH	04/09/2009SE
K081522	Bio Nuclear Diagnostics (Endo)Cervical Sampler for Gyn CytologyHHT · Traditional	Bio Nuclear Diagnostics, Inc.	12/05/2008SE
K072381	Softpap Cervical Cell CollectorHHT · Special	Cytocore, Inc.	01/30/2008SE
K062433	Diamics Cercol Cervical Sample Collector SystemHHT · Traditional	Diamics, Inc.	03/16/2007SE
K043369	Cervex-Brush CombiHHT · Traditional	Rovers Medical Devices B.V.	02/02/2005SE
K042527	Spatula, Cervical, Cytological, Model 22-9107HHT · Traditional	Medical Action Industries, Inc.	11/08/2004SE

More from Medical Action Industries, Inc.

510(k)	Device	Decision
K992618	RespalertBZH · Traditional	10/29/1999SE
K983204	Harwill Medical U-Klip Umbilical ClampHFW · Traditional	02/26/1999SE
K980550	Whistle WatchBZH · Traditional	08/27/1998SE

Questions and answers

When was Harwill Medical Cervitula Cervical Spatula cleared by the FDA?

Harwill Medical Cervitula Cervical Spatula (K983202) received a 510(k) decision of Substantially Equivalent on March 15, 1999, 182 days after the submission was received.

What is the product code of K983202?

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