510(k) K062406
- Device
- AESCULAP NEURO PATTIES
- Applicant
- AESCULAP, INC.
- 510(k) number
- K062406
- Product code
- HBA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-09-15
- Date received
- 2006-08-17
- Regulation
- 882.4700
- Classification name
- Neurosurgical Paddie
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LISA M BOYLE
- Address
- 3773 Corporate Pkwy. Center Valley PA US 18034 18034
FDA Registration Numbers#
- 3014334038
- 3013557562
- 3038718579
- 1055236
- 1055789
- 1047843
- 1045254
- 3004950768
- 3013298431
- 1060680
- 9680271
- 1417592
- 1048735
- 9611024
- 3027977504
- 3016761372
- 1319660
- 9612501
- 2244478
- 1043214
- 1221144
- 3012421607
- 1220477
- 3018094310
- 3011089435
- 3011862887
- 3012494290
- 1219313
- 2320762
- 1054241
- 1219071
- 3003418325
- 3030733800
- 3005663073
Source Documents#
Other 510(k) Records For Product Code HBA #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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