Product Code: HAO FDA class 1 21 CFR 882.4535

Instrument, Surgical, Non-Powered

Neurology

The Non-Powered Neurosurgical Instrument is a general category covering manual, non-motorized tools used during neurosurgical procedures, such as dissectors, elevators, curettes, and probes, for the manipulation and handling of neural and adjacent tissue. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HAO under regulation 21 CFR 882.4535 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.

View on FDA

510(k)s

FEI Numbers

211

Registration Numbers

211

Unique Applicants

Years Active

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Basic Information

Product Code: HAO
Device Class: FDA class 1
Regulation Number: 882.4535
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 4

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 34 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K220920	Matreneu Percutaneous Balloon Compression Kit	Sep 07, 2022	Substantially Equivalent	Shenzhen Shineyard Medical Device Co. , Ltd.
K940973	MULLAN GANGLION MICROCOMPRESSION SET	Sep 29, 1995	Substantially Equivalent	Cook, Inc.
K951492	RIB RESECTOR	May 18, 1995	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K943115	AUTO SUTURE PITUITARY SPINAL RONGEUR	Jul 25, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K942971	AUTO SUTURE SPINAL DISSECTOR	Jul 20, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K942970	AUTO SUTURE SPINAL ELEVATOR	Jul 20, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K942969	AUTO SUTURE SPINAL NERVE HOOK	Jul 20, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K942968	AUTO SUTURE SPINAL OSTEOTOME	Jul 20, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K942967	AUTO SUTURE SPINAL CURETTE	Jul 20, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K923723	SILICONE BRAIN SPATULA SET	Aug 12, 1992	Substantially Equivalent	Redmond Neurosurgical, Inc.
K910226	DURAL DISSECTORS	Feb 12, 1991	Substantially Equivalent	Acra Cut, Inc.
K910225	BONE PAD REMOVER	Feb 12, 1991	Substantially Equivalent	Acra Cut, Inc.
K902850	ZEPPELIN INSTRUMENTS	Jul 18, 1990	Substantially Equivalent	Ruggles Corp.
K892546	TAYLOR SPINAL RETRACTOR	May 11, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K882422	DISPOSABLE ARACHNOID KNIFE	Sep 06, 1988	Substantially Equivalent	Microbio-Medics, Inc.
K880278	MALLEABLE PTFE COATED BRAIN SPATULAE	Feb 11, 1988	Substantially Equivalent	Downs Surgical , Ltd.
K874962	FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS	Feb 02, 1988	Substantially Equivalent	Solway, Inc.
K874630	RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS	Dec 23, 1987	Substantially Equivalent	Downs Surgical , Ltd.
K863416	RAYLOR MINI-PROBE	Sep 24, 1986	Substantially Equivalent	Cedar Surgical, Inc.
K863415	RAYLOR BONE IMPACTORS	Sep 24, 1986	Substantially Equivalent	Cedar Surgical, Inc.
K862331	FUJITSU MALLEABLE - TIP BRAIN SPATULA	Jul 01, 1986	Substantially Equivalent	Downs Surgical , Ltd.
K861630	NEUROSURGICAL INSTURMENTS (VARIOUS)	May 09, 1986	Substantially Equivalent	Downs Surgical , Ltd.
K832343	DERMALAND DURAL HOOKS	Aug 12, 1983	Substantially Equivalent	National Fabtronix, Inc.
K822048	H-H NERVE ROOT RETRACTOR	Jul 22, 1982	Substantially Equivalent	Holter-Hausner Intl.
K821357	MODIFIED NEURO SURGERY NIBBLING FORCEPS	May 14, 1982	Substantially Equivalent	Downs Surgical , Ltd.
K802726	INSTRUMENTS NONSTERILE & STERILE	Nov 19, 1980	Substantially Equivalent	Ascep, Inc.
K801760	FIELD-LEE BRAIN BIOPSY NEEDLE	Sep 09, 1980	Substantially Equivalent	American V. Mueller
K780579	SUBCUPASS TUNNELING TOOL	May 19, 1978	Substantially Equivalent	Medtronic Vascular
K780520	VAS APPROXIMATOR	May 16, 1978	Substantially Equivalent	Edward Weck, Inc.
K772389	DANDY HEMOSTATIC FORCEPS	Jan 06, 1978	Substantially Equivalent	Edward Weck, Inc.
K772371	BAYONET SURGICAL INSTRUMENTS	Jan 06, 1978	Substantially Equivalent	Edward Weck, Inc.
K772013	PERCUPASS TUNNELING TOOL MODEL 3452	Oct 28, 1977	Substantially Equivalent	Medtronic Vascular
K761097	VANDERBILT BLADE HOLDER	Nov 30, 1976	Substantially Equivalent	Codman & Shurtleff, Inc.
K761095	VANDERBILT CURETTE	Nov 30, 1976	Substantially Equivalent	Codman & Shurtleff, Inc.