Product Code: HBA FDA class 2 21 CFR 882.4700

Neurosurgical Paddie

Neurology

The Neurosurgical Paddie is a small surgical sponge or pledget used in neurosurgical procedures to protect delicate neural tissue, absorb fluids, and aid in hemostasis within the operative field during procedures on the brain or spinal cord. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HBA under regulation 21 CFR 882.4700 in the Neurology specialty. It is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: HBA
Device Class: FDA class 2
Regulation Number: 882.4700
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K193346	Codman Surgical Patties & Strips	Nov 20, 2020	Substantially Equivalent	Integra LifeSciences Corporation
K140369	MEDLINE NEURO SPONGE	Sep 26, 2014	Substantially Equivalent	Medline Industries, Inc.
K112598	AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)	Jun 20, 2013	Substantially Equivalent	American Surgical Company, LLC
K121822	DELICOT	Sep 10, 2012	Substantially Equivalent	American Surgical Company, LLC
K073576	NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES	Feb 22, 2008	Substantially Equivalent	Harod Enterprises, Inc.
K062406	AESCULAP NEURO PATTIES	Sep 15, 2006	Substantially Equivalent	Aesculap, Inc.
K031008	AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)	May 09, 2003	Substantially Equivalent	Aesculap
K020736	TRAATEK COTTONOID PATTIES	Jun 03, 2002	Substantially Equivalent	Traatek, Inc.
K014268	NORAPAD PLAIN; NORAPAD TA	Mar 27, 2002	Substantially Equivalent	Perlei Medical, Inc.
K993019	PACIFIC SURGICAL PATTIES	Mar 30, 2000	Substantially Equivalent	V. Mueller Neuro/Spine
K973083	ULTRACELL NEURO SPONGES	Dec 09, 1997	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K962807	AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES	May 02, 1997	Substantially Equivalent	American Surgical Sponges
K970328	ULTRACELL NEURO SPONGES	Apr 21, 1997	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K950647	ULTRACELL NEURO SPONGES	Aug 15, 1995	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K914600	NEUROLOGICAL SPONGE	Dec 30, 1992	Substantially Equivalent	I M, Inc.
K923027	NEURAY SURGICAL PATTIES AND STRIPS	Aug 28, 1992	Substantially Equivalent	Martland Healthcare, Inc.
K904514	STRUNG TELFA NON-ADHERENT SPONGE	Mar 27, 1991	Substantially Equivalent	American Silk Sutures, Inc.
K902921	RAYON NEUROLOGICAL SPONGE	Sep 18, 1990	Substantially Equivalent	American Silk Sutures, Inc.
K891993	COLLAGEN NEUROSPONGE	Mar 23, 1990	Substantially Equivalent	Vitaphore Corp.
K880402	CODMAN SURGICAL PATTIE	Mar 02, 1988	Substantially Equivalent	Codman & Shurtleff, Inc.
K862494	POLYESTER SPONGE PATTIE	Jul 30, 1986	Substantially Equivalent	American Silk Sutures, Inc.
K854713	COTTON NEUROLOGICAL SPONGE	Mar 20, 1986	Substantially Equivalent	American Silk Sutures, Inc.
K844594	NEURO CUSTOM SURGICAL KIT	Jun 13, 1985	Substantially Equivalent	Xanmed Corp.
K770894	NEURO-SORB PATTIES	Jun 20, 1977	Substantially Equivalent	Instranetics, Inc.