Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4700](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4700) → HBA — Neurosurgical Paddie # HBA · Neurosurgical Paddie _Neurology · 21 CFR 882.4700 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA ## Overview - **Product Code:** HBA - **Device Name:** Neurosurgical Paddie - **Regulation:** [21 CFR 882.4700](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4700) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K193346.md) | Codman Surgical Patties & Strips | Integra LifeSciences Corporation | Nov 20, 2020 | SESE | | [K140369](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K140369.md) | MEDLINE NEURO SPONGE | Medline Industries, Inc. | Sep 26, 2014 | SESE | | [K112598](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K112598.md) | AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) | American Surgical Company, LLC | Jun 20, 2013 | SESE | | [K121822](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K121822.md) | DELICOT | American Surgical Company, LLC | Sep 10, 2012 | SESE | | [K073576](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K073576.md) | NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES | Harod Enterprises, Inc. | Feb 22, 2008 | SESE | | [K062406](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K062406.md) | AESCULAP NEURO PATTIES | Aesculap, Inc. | Sep 15, 2006 | SESE | | [K031008](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K031008.md) | AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) | Aesculap | May 9, 2003 | SESE | | [K020736](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K020736.md) | TRAATEK COTTONOID PATTIES | Traatek, Inc. | Jun 3, 2002 | SESE | | [K014268](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K014268.md) | NORAPAD PLAIN; NORAPAD TA | Perlei Medical, Inc. | Mar 27, 2002 | SESE | | [K993019](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K993019.md) | PACIFIC SURGICAL PATTIES | V. Mueller Neuro/Spine | Mar 30, 2000 | SESE | | [K973083](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K973083.md) | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | Dec 9, 1997 | SESE | | [K962807](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K962807.md) | AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES | American Surgical Sponges | May 2, 1997 | SESE | | [K970328](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K970328.md) | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | Apr 21, 1997 | SESE | | [K950647](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K950647.md) | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | Aug 15, 1995 | SESE | | [K914600](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K914600.md) | NEUROLOGICAL SPONGE | I M, Inc. | Dec 30, 1992 | SESE | | [K923027](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K923027.md) | NEURAY SURGICAL PATTIES AND STRIPS | Martland Healthcare, Inc. | Aug 28, 1992 | SESE | | [K904514](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K904514.md) | STRUNG TELFA NON-ADHERENT SPONGE | American Silk Sutures, Inc. | Mar 27, 1991 | SESE | | [K902921](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K902921.md) | RAYON NEUROLOGICAL SPONGE | American Silk Sutures, Inc. | Sep 18, 1990 | SESE | | [K891993](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K891993.md) | COLLAGEN NEUROSPONGE | Vitaphore Corp. | Mar 23, 1990 | SESE | | [K880402](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K880402.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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