Ultracell Neuro Sponges

FDA 510(k) K970328 · Ultracell Medical Technologies, Inc.

Substantially Equivalent

510(k) numberK970328

Submission

Device name
Ultracell Neuro Sponges
Applicant
Ultracell Medical Technologies, Inc.
North Stonington, CT, US
Received
January 27, 1997
Decision date
April 21, 1997
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
K020736Traatek Cottonoid PattiesHBA · Traditional Traatek, Inc.06/03/2002SE
K014268Norapad Plain; Norapad TaHBA · Traditional Perlei Medical, Inc.03/27/2002SE
K993019Pacific Surgical PattiesHBA · Traditional V. Mueller Neuro/Spine03/30/2000SE

More from V. Mueller Neuro/Spine

510(k)DeviceDecision
K012196Ultracell Absorbent StickHOZ · Traditional 08/24/2001SE
K972634Ultracell Suction SpongeGDY · Traditional 12/17/1997SE
K972633Ultracell Suction SpongeHOZ · Traditional 12/17/1997SE
K973083Ultracell Neuro SpongesHBA · Traditional 12/09/1997SE
K973558Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus)FEB · Traditional 11/24/1997SE
K973085Ultracell Packing with SleeveEMX · Traditional 11/18/1997SE
K972635Ultracell Suction SpongeGBX · Traditional 10/01/1997SE
K950647Ultracell Neuro SpongesHBA · Traditional 08/15/1995SE
K950373Ultracell Orthopedic SpongesGDY · Traditional 04/17/1995SE
K950372Ultracell Orthopedic SpongesGDY · Traditional 04/17/1995SE

Questions and answers

When was Ultracell Neuro Sponges cleared by the FDA?

Ultracell Neuro Sponges (K970328) received a 510(k) decision of Substantially Equivalent on April 21, 1997, 84 days after the submission was received.

What is the product code of K970328?

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