Medline Neuro Sponge
FDA 510(k) K140369 · Medline Industries, Inc.
510(k) numberK140369
Submission
- Device name
- Medline Neuro Sponge
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- February 14, 2014
- Decision date
- September 26, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K073576 | Neurosurgical Sponges and Paddles and Neuro Patties and NeurospongesHBA · Traditional | Harod Enterprises, Inc. | 02/22/2008SE |
| 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 |
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Questions and answers
When was Medline Neuro Sponge cleared by the FDA?
Medline Neuro Sponge (K140369) received a 510(k) decision of Substantially Equivalent on September 26, 2014, 224 days after the submission was received.
What is the product code of K140369?
The FDA product code is HBA – Neurosurgical Paddie, a Class II (moderate risk) device regulated under 21 CFR 882.4700.