HAO · Instrument, Surgical, Non-Powered
Neurology · 21 CFR 882.4535 · Class 1
Overview
| Product Code | HAO |
|---|---|
| Device Name | Instrument, Surgical, Non-Powered |
| Regulation | 21 CFR 882.4535 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Cleared Devices (34)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220920 | Matreneu Percutaneous Balloon Compression Kit | Shenzhen Shineyard Medical Device Co. , Ltd. | Sep 7, 2022 | SESE |
| K940973 | MULLAN GANGLION MICROCOMPRESSION SET | Cook, Inc. | Sep 29, 1995 | SESE |
| K951492 | RIB RESECTOR | United States Surgical, A Division of Tyco Healthc | May 18, 1995 | SESE |
| K943115 | AUTO SUTURE PITUITARY SPINAL RONGEUR | United States Surgical, A Division of Tyco Healthc | Jul 25, 1994 | SESE |
| K942971 | AUTO SUTURE SPINAL DISSECTOR | United States Surgical, A Division of Tyco Healthc | Jul 20, 1994 | SESE |
| K942970 | AUTO SUTURE SPINAL ELEVATOR | United States Surgical, A Division of Tyco Healthc | Jul 20, 1994 | SESE |
| K942969 | AUTO SUTURE SPINAL NERVE HOOK | United States Surgical, A Division of Tyco Healthc | Jul 20, 1994 | SESE |
| K942968 | AUTO SUTURE SPINAL OSTEOTOME | United States Surgical, A Division of Tyco Healthc | Jul 20, 1994 | SESE |
| K942967 | AUTO SUTURE SPINAL CURETTE | United States Surgical, A Division of Tyco Healthc | Jul 20, 1994 | SESE |
| K923723 | SILICONE BRAIN SPATULA SET | Redmond Neurosurgical, Inc. | Aug 12, 1992 | SESE |
| K910226 | DURAL DISSECTORS | Acra Cut, Inc. | Feb 12, 1991 | SESE |
| K910225 | BONE PAD REMOVER | Acra Cut, Inc. | Feb 12, 1991 | SESE |
| K902850 | ZEPPELIN INSTRUMENTS | Ruggles Corp. | Jul 18, 1990 | SESE |
| K892546 | TAYLOR SPINAL RETRACTOR | Zinnanti Surgical Instruments, Inc. | May 11, 1989 | SESE |
| K882422 | DISPOSABLE ARACHNOID KNIFE | Microbio-Medics, Inc. | Sep 6, 1988 | SESE |
| K880278 | MALLEABLE PTFE COATED BRAIN SPATULAE | Downs Surgical , Ltd. | Feb 11, 1988 | SESE |
| K874962 | FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS | Solway, Inc. | Feb 2, 1988 | SESE |
| K874630 | RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS | Downs Surgical , Ltd. | Dec 23, 1987 | SESE |
| K863416 | RAYLOR MINI-PROBE | Cedar Surgical, Inc. | Sep 24, 1986 | SESE |
| K863415 | RAYLOR BONE IMPACTORS | Cedar Surgical, Inc. | Sep 24, 1986 | SESE |
| K862331 | FUJITSU MALLEABLE - TIP BRAIN SPATULA | Downs Surgical , Ltd. | Jul 1, 1986 | SESE |
| K861630 | NEUROSURGICAL INSTURMENTS (VARIOUS) | Downs Surgical , Ltd. | May 9, 1986 | SESE |
| K832343 | DERMALAND DURAL HOOKS | National Fabtronix, Inc. | Aug 12, 1983 | SESE |
| K822048 | H-H NERVE ROOT RETRACTOR | Holter-Hausner Intl. | Jul 22, 1982 | SESE |
| K821357 | MODIFIED NEURO SURGERY NIBBLING FORCEPS | Downs Surgical , Ltd. | May 14, 1982 | SESE |
| K802726 | INSTRUMENTS NONSTERILE & STERILE | Ascep, Inc. | Nov 19, 1980 | SESE |
| K801760 | FIELD-LEE BRAIN BIOPSY NEEDLE | American V. Mueller | Sep 9, 1980 | SESE |
| K780579 | SUBCUPASS TUNNELING TOOL | Medtronic Vascular | May 19, 1978 | SESE |
| K780520 | VAS APPROXIMATOR | Edward Weck, Inc. | May 16, 1978 | SESE |
| K772389 | DANDY HEMOSTATIC FORCEPS | Edward Weck, Inc. | Jan 6, 1978 | SESE |
| K772371 | BAYONET SURGICAL INSTRUMENTS | Edward Weck, Inc. | Jan 6, 1978 | SESE |
| K772013 | PERCUPASS TUNNELING TOOL MODEL 3452 | Medtronic Vascular | Oct 28, 1977 | SESE |
| K761097 | VANDERBILT BLADE HOLDER | Codman & Shurtleff, Inc. | Nov 30, 1976 | SESE |
| K761095 | VANDERBILT CURETTE | Codman & Shurtleff, Inc. | Nov 30, 1976 | SESE |
Top Applicants
- United States Surgical, A Division of Tyco Healthc — 7 clearances
- Downs Surgical , Ltd. — 5 clearances
- Edward Weck, Inc. — 3 clearances
- Medtronic Vascular — 2 clearances
- Codman & Shurtleff, Inc. — 2 clearances
