Neurosurgical Sponges and Paddles and Neuro Patties and Neurosponges

Q: What is the product code of K073576?

The FDA product code is HBA – Neurosurgical Paddie, a Class II (moderate risk) device regulated under 21 CFR 882.4700.

FDA 510(k) K073576 · Harod Enterprises, Inc.

Substantially Equivalent

510(k) numberK073576

Submission

Device name: Neurosurgical Sponges and Paddles and Neuro Patties and Neurosponges
Applicant: Harod Enterprises, Inc.
Martinez, GA, US
Received: December 19, 2007
Decision date: February 22, 2008
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HBA – Neurosurgical Paddie
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4700
Specialty: Neurology

Other 510(k)s with product code HBA

510(k)	Device	Applicant	Decision
K193346	Codman Surgical Patties & StripsHBA · Traditional	Integra LifeSciences Corporation	11/20/2020SE
K140369	Medline Neuro SpongeHBA · Traditional	Medline Industries, Inc.	09/26/2014SE
K112598	American Surgical Company/ Neurosurgical Sponges (Brand)HBA · Special	American Surgical Company, LLC	06/20/2013SE
K121822	DelicotHBA · Special	American Surgical Company, LLC	09/10/2012SE
K062406	Aesculap Neuro PattiesHBA · Special	Aesculap, Inc.	09/15/2006SE
K031008	Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White)HBA · Traditional	Aesculap	05/09/2003SE
K020736	Traatek Cottonoid PattiesHBA · Traditional	Traatek, Inc.	06/03/2002SE
K014268	Norapad Plain; Norapad TaHBA · Traditional	Perlei Medical, Inc.	03/27/2002SE
K993019	Pacific Surgical PattiesHBA · Traditional	V. Mueller Neuro/Spine	03/30/2000SE
K973083	Ultracell Neuro SpongesHBA · Traditional	Ultracell Medical Technologies, Inc.	12/09/1997SE

Questions and answers

When was Neurosurgical Sponges and Paddles and Neuro Patties and Neurosponges cleared by the FDA?

Neurosurgical Sponges and Paddles and Neuro Patties and Neurosponges (K073576) received a 510(k) decision of Substantially Equivalent on February 22, 2008, 65 days after the submission was received.

What is the product code of K073576?

The FDA product code is HBA – Neurosurgical Paddie, a Class II (moderate risk) device regulated under 21 CFR 882.4700.