FDA Product Code
FDA Product Code HBA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4700
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K193346 | Codman Surgical Patties & Strips | Integra LifeSciences Corporation | 2020-11-20 | Traditional | PDF ↗ |
| K140369 | MEDLINE NEURO SPONGE | Medline Industries, Inc. | 2014-09-26 | Traditional | PDF ↗ |
| K112598 | AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) | American Surgical Company, LLC | 2013-06-20 | Special | PDF ↗ |
| K121822 | DELICOT | American Surgical Company, LLC | 2012-09-10 | Special | PDF ↗ |
| K073576 | NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES | Harod Enterprises, Inc. | 2008-02-22 | Traditional | PDF ↗ |
| K062406 | AESCULAP NEURO PATTIES | Aesculap, Inc. | 2006-09-15 | Special | PDF ↗ |
| K031008 | AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) | Aesculap | 2003-05-09 | Traditional | PDF ↗ |
| K020736 | TRAATEK COTTONOID PATTIES | Traatek, Inc. | 2002-06-03 | Traditional | PDF ↗ |
| K014268 | NORAPAD PLAIN; NORAPAD TA | Perlei Medical, Inc. | 2002-03-27 | Traditional | PDF ↗ |
| K993019 | PACIFIC SURGICAL PATTIES | V. Mueller Neuro/Spine | 2000-03-30 | Traditional | PDF ↗ |
| K973083 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | 1997-12-09 | Traditional | PDF ↗ |
| K962807 | AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES | American Surgical Sponges | 1997-05-02 | Traditional | PDF ↗ |
| K970328 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | 1997-04-21 | Traditional | PDF ↗ |
| K950647 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K914600 | NEUROLOGICAL SPONGE | I M, Inc. | 1992-12-30 | Traditional | PDF ↗ |
| K923027 | NEURAY SURGICAL PATTIES AND STRIPS | Martland Healthcare, Inc. | 1992-08-28 | Traditional | PDF ↗ |
| K904514 | STRUNG TELFA NON-ADHERENT SPONGE | American Silk Sutures, Inc. | 1991-03-27 | Traditional | PDF ↗ |
| K902921 | RAYON NEUROLOGICAL SPONGE | American Silk Sutures, Inc. | 1990-09-18 | Traditional | PDF ↗ |
| K891993 | COLLAGEN NEUROSPONGE | Vitaphore Corp. | 1990-03-23 | Traditional | PDF ↗ |
| K880402 | CODMAN SURGICAL PATTIE | Codman & Shurtleff, Inc. | 1988-03-02 | Traditional | PDF ↗ |
| K862494 | POLYESTER SPONGE PATTIE | American Silk Sutures, Inc. | 1986-07-30 | Traditional | PDF ↗ |
| K854713 | COTTON NEUROLOGICAL SPONGE | American Silk Sutures, Inc. | 1986-03-20 | Traditional | PDF ↗ |
| K844594 | NEURO CUSTOM SURGICAL KIT | Xanmed Corp. | 1985-06-13 | Traditional | PDF ↗ |
| K770894 | NEURO-SORB PATTIES | Instranetics, Inc. | 1977-06-20 | Traditional | PDF ↗ |
Product code HBA · Class II · Neurology. Data: openFDA.