Traatek Cottonoid Patties

FDA 510(k) K020736 · Traatek, Inc.

Substantially Equivalent

510(k) numberK020736

Submission

Device name
Traatek Cottonoid Patties
Applicant
Traatek, Inc.
Redwood City, CA, US
Received
March 6, 2002
Decision date
June 3, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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)DeviceApplicantDecision
K193346Codman Surgical Patties & StripsHBA · Traditional Integra LifeSciences Corporation11/20/2020SE
K140369Medline Neuro SpongeHBA · Traditional Medline Industries, Inc.09/26/2014SE
K112598American Surgical Company/ Neurosurgical Sponges (Brand)HBA · Special American Surgical Company, LLC06/20/2013SE
K121822DelicotHBA · Special American Surgical Company, LLC09/10/2012SE
K073576Neurosurgical Sponges and Paddles and Neuro Patties and NeurospongesHBA · Traditional Harod Enterprises, Inc.02/22/2008SE
K062406Aesculap Neuro PattiesHBA · Special Aesculap, Inc.09/15/2006SE
K031008Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White)HBA · Traditional Aesculap05/09/2003SE
K014268Norapad Plain; Norapad TaHBA · Traditional Perlei Medical, Inc.03/27/2002SE
K993019Pacific Surgical PattiesHBA · Traditional V. Mueller Neuro/Spine03/30/2000SE
K973083Ultracell Neuro SpongesHBA · Traditional Ultracell Medical Technologies, Inc.12/09/1997SE

Questions and answers

When was Traatek Cottonoid Patties cleared by the FDA?

Traatek Cottonoid Patties (K020736) received a 510(k) decision of Substantially Equivalent on June 3, 2002, 89 days after the submission was received.

What is the product code of K020736?

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