Safetex Cervical Scraper (Plastic)

FDA 510(k) K983428 · Andwin Scientific

Substantially Equivalent

510(k) numberK983428

Submission

Device name
Safetex Cervical Scraper (Plastic)
Applicant
Andwin Scientific
Woodland Hills, CA, US
Received
September 29, 1998
Decision date
November 16, 1998
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

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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

More from Medical Action Industries, Inc.

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K983599Safetex Chlamydia Trachomatis Specimen Collection KitHHT · Traditional 12/11/1998SE
K964698Safetex Combination Blood (Alcohol, Ethyl) / Urine Collection and Transport KitJKA · Traditional 03/03/1997SE

Questions and answers

When was Safetex Cervical Scraper (Plastic) cleared by the FDA?

Safetex Cervical Scraper (Plastic) (K983428) received a 510(k) decision of Substantially Equivalent on November 16, 1998, 48 days after the submission was received.

What is the product code of K983428?

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