Product code HBA
- Device name
- Neurosurgical Paddie
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4700
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193346 | Codman Surgical Patties & Strips | Integra LifeSciences Corporation | 2020-11-20 |
| K140369 | MEDLINE NEURO SPONGE | Medline Industries, Inc. | 2014-09-26 |
| K112598 | AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) | American Surgical Company, LLC | 2013-06-20 |
| K121822 | DELICOT | American Surgical Company, LLC | 2012-09-10 |
| K073576 | NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES | Harod Enterprises, Inc. | 2008-02-22 |
| K062406 | AESCULAP NEURO PATTIES | Aesculap, Inc. | 2006-09-15 |
| K031008 | AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) | Aesculap | 2003-05-09 |
| K020736 | TRAATEK COTTONOID PATTIES | Traatek, Inc. | 2002-06-03 |
| K014268 | NORAPAD PLAIN; NORAPAD TA | Perlei Medical, Inc. | 2002-03-27 |
| K993019 | PACIFIC SURGICAL PATTIES | V. Mueller Neuro/Spine | 2000-03-30 |
| K973083 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | 1997-12-09 |
| K962807 | AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES | American Surgical Sponges | 1997-05-02 |
| K970328 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | 1997-04-21 |
| K950647 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | 1995-08-15 |
| K914600 | NEUROLOGICAL SPONGE | I M, Inc. | 1992-12-30 |
| K923027 | NEURAY SURGICAL PATTIES AND STRIPS | Martland Healthcare, Inc. | 1992-08-28 |
| K904514 | STRUNG TELFA NON-ADHERENT SPONGE | American Silk Sutures, Inc. | 1991-03-27 |
| K902921 | RAYON NEUROLOGICAL SPONGE | American Silk Sutures, Inc. | 1990-09-18 |
| K891993 | COLLAGEN NEUROSPONGE | Vitaphore Corp. | 1990-03-23 |
| K880402 | CODMAN SURGICAL PATTIE | Codman & Shurtleff, Inc. | 1988-03-02 |
| K862494 | POLYESTER SPONGE PATTIE | American Silk Sutures, Inc. | 1986-07-30 |
| K854713 | COTTON NEUROLOGICAL SPONGE | American Silk Sutures, Inc. | 1986-03-20 |
| K844594 | NEURO CUSTOM SURGICAL KIT | Xanmed Corp. | 1985-06-13 |
| K770894 | NEURO-SORB PATTIES | Instranetics, Inc. | 1977-06-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10381780514923 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515135 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515128 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515111 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515104 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515098 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515081 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515074 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515067 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515050 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515043 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515036 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515012 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780514930 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780514947 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780514954 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780514961 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780514978 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780514985 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780514992 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515005 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780515029 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 00763000032845 | Neuray® | MEDTRONIC XOMED, INC. | 2019-03-23 |
| 00763000032746 | Neuray® | MEDTRONIC XOMED, INC. | 2019-03-17 |
| 00763000032784 | Neuray® | MEDTRONIC XOMED, INC. | 2019-03-17 |
| 00763000032791 | Neuray® | MEDTRONIC XOMED, INC. | 2019-03-17 |
| 00763000032807 | Neuray® | MEDTRONIC XOMED, INC. | 2019-03-17 |
| 00763000032814 | Neuray® | MEDTRONIC XOMED, INC. | 2019-03-17 |
| 00763000032821 | Neuray® | MEDTRONIC XOMED, INC. | 2019-03-17 |
| 00763000032838 | Neuray® | MEDTRONIC XOMED, INC. | 2019-03-17 |