Atlas FDA

HBA

24 FDA 510(k) clearances · Product code

113 daysmedian time to decision
360 days90th percentile
24clearances measured

FDA profile

Official device name
Neurosurgical Paddie
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4700
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2020: 31 · 2021: 44 · 2022: 28 · 2023: 29 · 2024: 27 · 2026: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Codman Surgical Patties & Strips (K193346)Integra LifeSciences Corporation2020-11-20
MEDLINE NEURO SPONGE (K140369)Medline Industries, Inc.2014-09-26
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) (K112598)American Surgical Company, LLC2013-06-20
DELICOT (K121822)American Surgical Company, LLC2012-09-10
NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES (K073576)Harod Enterprises, Inc.2008-02-22
AESCULAP NEURO PATTIES (K062406)Aesculap, Inc.2006-09-15
AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) (K031008)Aesculap2003-05-09
TRAATEK COTTONOID PATTIES (K020736)Traatek, Inc.2002-06-03
NORAPAD PLAIN; NORAPAD TA (K014268)Perlei Medical, Inc.2002-03-27
PACIFIC SURGICAL PATTIES (K993019)V. Mueller Neuro/Spine2000-03-30
ULTRACELL NEURO SPONGES (K973083)Ultracell Medical Technologies, Inc.1997-12-09
AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES (K962807)American Surgical Sponges1997-05-02
ULTRACELL NEURO SPONGES (K970328)Ultracell Medical Technologies, Inc.1997-04-21
ULTRACELL NEURO SPONGES (K950647)Ultracell Medical Technologies, Inc.1995-08-15
NEUROLOGICAL SPONGE (K914600)I M, Inc.1992-12-30
NEURAY SURGICAL PATTIES AND STRIPS (K923027)Martland Healthcare, Inc.1992-08-28
STRUNG TELFA NON-ADHERENT SPONGE (K904514)American Silk Sutures, Inc.1991-03-27
RAYON NEUROLOGICAL SPONGE (K902921)American Silk Sutures, Inc.1990-09-18
COLLAGEN NEUROSPONGE (K891993)Vitaphore Corp.1990-03-23
CODMAN SURGICAL PATTIE (K880402)Codman & Shurtleff, Inc.1988-03-02
POLYESTER SPONGE PATTIE (K862494)American Silk Sutures, Inc.1986-07-30
COTTON NEUROLOGICAL SPONGE (K854713)American Silk Sutures, Inc.1986-03-20
NEURO CUSTOM SURGICAL KIT (K844594)Xanmed Corp.1985-06-13
NEURO-SORB PATTIES (K770894)Instranetics, Inc.1977-06-20

Track HBA automatically

Every clearance here is in the API, with alerts when new ones post.