Delicot
FDA 510(k) K121822 · American Surgical Company, LLC
510(k) numberK121822
Submission
- Device name
- Delicot
- Applicant
- American Surgical Company, LLC
Lynn, MA, US - Received
- June 21, 2012
- Decision date
- September 10, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
More from Ultracell Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K112598 | American Surgical Company/ Neurosurgical Sponges (Brand)HBA · Special | 06/20/2013SE |
| K834162 | Vit PacHQE · Traditional | 02/07/1986SE |
| K834160 | Vitreonic PlusHQE · Traditional | 02/07/1986SE |
| K841738 | Amer. Surgical Corp. Extra Plus PakHQE · Traditional | 10/05/1984SE |
| K834163 | UltravitHQE · Traditional | 12/28/1983SE |
| K834161 | Universal PacHQC · Traditional | 12/28/1983SE |
| K834159 | Phacotron PlusHQC · Traditional | 12/28/1983SE |
| K834158 | Extra Sensory PlusHQC · Traditional | 12/28/1983SE |
| K833697 | Extra Sensory Pak-Dispos. AccessHQC · Traditional | 12/28/1983SE |
| K833617 | Extra Plus TMHQC · Traditional | 12/28/1983SE |
Questions and answers
When was Delicot cleared by the FDA?
Delicot (K121822) received a 510(k) decision of Substantially Equivalent on September 10, 2012, 81 days after the submission was received.
What is the product code of K121822?
The FDA product code is HBA – Neurosurgical Paddie, a Class II (moderate risk) device regulated under 21 CFR 882.4700.