HBA · Neurosurgical Paddie
Neurology · 21 CFR 882.4700 · Class 2
Overview
| Product Code | HBA |
|---|---|
| Device Name | Neurosurgical Paddie |
| Regulation | 21 CFR 882.4700 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K193346 | Codman Surgical Patties & Strips | Integra LifeSciences Corporation | Nov 20, 2020 | SESE |
| K140369 | MEDLINE NEURO SPONGE | Medline Industries, Inc. | Sep 26, 2014 | SESE |
| K112598 | AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) | American Surgical Company, LLC | Jun 20, 2013 | SESE |
| K121822 | DELICOT | American Surgical Company, LLC | Sep 10, 2012 | SESE |
| K073576 | NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES | Harod Enterprises, Inc. | Feb 22, 2008 | SESE |
| K062406 | AESCULAP NEURO PATTIES | Aesculap, Inc. | Sep 15, 2006 | SESE |
| K031008 | AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) | Aesculap | May 9, 2003 | SESE |
| K020736 | TRAATEK COTTONOID PATTIES | Traatek, Inc. | Jun 3, 2002 | SESE |
| K014268 | NORAPAD PLAIN; NORAPAD TA | Perlei Medical, Inc. | Mar 27, 2002 | SESE |
| K993019 | PACIFIC SURGICAL PATTIES | V. Mueller Neuro/Spine | Mar 30, 2000 | SESE |
| K973083 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | Dec 9, 1997 | SESE |
| K962807 | AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES | American Surgical Sponges | May 2, 1997 | SESE |
| K970328 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | Apr 21, 1997 | SESE |
| K950647 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | Aug 15, 1995 | SESE |
| K914600 | NEUROLOGICAL SPONGE | I M, Inc. | Dec 30, 1992 | SESE |
| K923027 | NEURAY SURGICAL PATTIES AND STRIPS | Martland Healthcare, Inc. | Aug 28, 1992 | SESE |
| K904514 | STRUNG TELFA NON-ADHERENT SPONGE | American Silk Sutures, Inc. | Mar 27, 1991 | SESE |
| K902921 | RAYON NEUROLOGICAL SPONGE | American Silk Sutures, Inc. | Sep 18, 1990 | SESE |
| K891993 | COLLAGEN NEUROSPONGE | Vitaphore Corp. | Mar 23, 1990 | SESE |
| K880402 | CODMAN SURGICAL PATTIE | Codman & Shurtleff, Inc. | Mar 2, 1988 | SESE |
Top Applicants
- American Silk Sutures, Inc. — 4 clearances
- Ultracell Medical Technologies, Inc. — 3 clearances
- American Surgical Company, LLC — 2 clearances
- Aesculap — 1 clearance
- Aesculap, Inc. — 1 clearance
