Neurological Sponge
FDA 510(k) K914600 · I M, Inc.
510(k) numberK914600
Submission
- Device name
- Neurological Sponge
- Applicant
- I M, Inc.
Fairfield, NJ, US - Received
- October 11, 1991
- Decision date
- December 30, 1992
- 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 |
| 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 |
| 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 |
More from V. Mueller Neuro/Spine
| 510(k) | Device | Decision |
|---|---|---|
| K892389 | Biopsy KitLRO · Traditional | 07/17/1989SESD |
| K881363 | Syringe Prefilled with WaterKOD · Traditional | 06/23/1988SE |
| K880753 | Umbilical Cord ClampHFW · Traditional | 04/27/1988SE |
| K872741 | NutripumpFRN · Traditional | 10/20/1987SE |
| K871495 | Bandages Catalog Number: 101 to 220NAD · Traditional | 05/08/1987SE |
| K863785 | Makler CatheterHDR · Traditional | 12/11/1986SE |
| K854155 | Sterile Saline SolutionKMJ · Traditional | 12/10/1985SE |
| K853287 | HuboutFPA · Traditional | 10/17/1985SE |
| K853288 | Feeding Units & TubesKNT · Traditional | 10/04/1985SE |
| K853286 | Staple Remover · Traditional | 08/21/1985SE |
Questions and answers
When was Neurological Sponge cleared by the FDA?
Neurological Sponge (K914600) received a 510(k) decision of Substantially Equivalent on December 30, 1992, 446 days after the submission was received.
What is the product code of K914600?
The FDA product code is HBA – Neurosurgical Paddie, a Class II (moderate risk) device regulated under 21 CFR 882.4700.