Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White)
FDA 510(k) K031008 · Aesculap
510(k) numberK031008
Submission
- Device name
- Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White)
- Applicant
- Aesculap
Center Valley, PA, US - Received
- March 31, 2003
- Decision date
- May 9, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| 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 |
| 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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| K223596 | SQ.line KERRISONHAE · Traditional | 06/29/2023SE |
| K214041 | Aesculap AICON ContainerKCT · Traditional | 12/30/2022SE |
| K211572 | Aesculap Slim Clip ApplierHCI · Traditional | 12/13/2021SE |
| K203739 | ELAN 4 Electro Motor SystemHBE · Traditional | 08/24/2021SE |
| K202391 | Dir 800IZI · Traditional | 01/21/2021SE |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology SystemGEI · Special | 12/18/2020SE |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology SystemGEI · Special | 10/30/2020SE |
| K202124 | Aesculap PAS-Port Proximal Anastomosis SystemFZP · Special | 09/02/2020SE |
Questions and answers
When was Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White) cleared by the FDA?
Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White) (K031008) received a 510(k) decision of Substantially Equivalent on May 9, 2003, 39 days after the submission was received.
What is the product code of K031008?
The FDA product code is HBA – Neurosurgical Paddie, a Class II (moderate risk) device regulated under 21 CFR 882.4700.