Collagen Neurosponge
FDA 510(k) K891993 · Vitaphore Corp.
510(k) numberK891993
Submission
- Device name
- Collagen Neurosponge
- Applicant
- Vitaphore Corp.
Menlo Park, CA, US - Received
- March 28, 1989
- Decision date
- March 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K914579 | Silver Foam Wound DressingFRO · Traditional | 02/21/1992SE |
| K913148 | Collagen Shield for Acute CareMOE · Traditional | 10/15/1991SE |
| K895920 | Vitapatch Pin Protection Device for PercutaneousKGX · Traditional | 06/06/1991SE |
| K902558 | Collagen Shield for Acute CareMOE · Traditional | 08/17/1990SE |
| K896455 | Vitachoice Wound DressingKGX · Traditional | 02/15/1990SE |
| K896046 | Vitapatch Cath. Securement Device W/ChlorhexidineKMK · Traditional | 01/11/1990SE |
| K895993 | Vitapatch Antimicrobial Catheter Securement DeviceKMK · Traditional | 01/11/1990SE |
| K890435 | Vitaaccess Catheter Introducer KitFOZ · Traditional | 03/29/1989SESD |
| K882100 | Vitacuff(R) Percutaneous Infect. Control KitLJS · Traditional | 07/13/1988SE |
| K872998 | Vitaaccess (TM) Catheter Introducer SystemFOZ · Traditional | 03/24/1988SE |
Questions and answers
When was Collagen Neurosponge cleared by the FDA?
Collagen Neurosponge (K891993) received a 510(k) decision of Substantially Equivalent on March 23, 1990, 360 days after the submission was received.
What is the product code of K891993?
The FDA product code is HBA – Neurosurgical Paddie, a Class II (moderate risk) device regulated under 21 CFR 882.4700.