ULTRACELL NEURO SPONGES
FDA 510(k) clearance K973083 · decided 1997-12-09
Clearance details
- K-number
- K973083
- Device name
- ULTRACELL NEURO SPONGES
- Applicant
- Ultracell Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-18
- Decision date
- 1997-12-09
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- HBA
- Device class
- 2
- Regulation number
- 882.4700
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- North Stonington, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Codman Surgical Patties & Strips (K193346) | Integra LifeSciences Corporation | 2020-11-20 |
| MEDLINE NEURO SPONGE (K140369) | Medline Industries, Inc. | 2014-09-26 |
| AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) (K112598) | American Surgical Company, LLC | 2013-06-20 |
| DELICOT (K121822) | American Surgical Company, LLC | 2012-09-10 |
| NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES (K073576) | Harod Enterprises, Inc. | 2008-02-22 |
| AESCULAP NEURO PATTIES (K062406) | Aesculap, Inc. | 2006-09-15 |
| AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) (K031008) | Aesculap | 2003-05-09 |
| TRAATEK COTTONOID PATTIES (K020736) | Traatek, Inc. | 2002-06-03 |
| NORAPAD PLAIN; NORAPAD TA (K014268) | Perlei Medical, Inc. | 2002-03-27 |
| PACIFIC SURGICAL PATTIES (K993019) | V. Mueller Neuro/Spine | 2000-03-30 |
| AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES (K962807) | American Surgical Sponges | 1997-05-02 |
| ULTRACELL NEURO SPONGES (K970328) | Ultracell Medical Technologies, Inc. | 1997-04-21 |
Recalls involving this device
No recalls on record reference this clearance.