Instrument, Surgical, Non-Powered
FDA product code HAO · Class I (low risk) · 21 CFR 882.4535 · Neurology
34510(k) clearances
0PMA approvals
2recalls
Manufacturers
- United States Surgical, A Division of Tyco Healthc 7
- Downs Surgical , Ltd. 5
- Edward Weck, Inc. 3
- Medtronic Vascular 2
- Codman & Shurtleff, Inc. 2
- Cedar Surgical, Inc. 2
- Acra Cut, Inc. 2
- Shenzhen Shineyard Medical Device Co. , Ltd. 1
- Cook, Inc. 1
- Redmond Neurosurgical, Inc. 1
- Ruggles Corp. 1
- Zinnanti Surgical Instruments, Inc. 1
- Microbio-Medics, Inc. 1
- Solway, Inc. 1
- National Fabtronix, Inc. 1
- Holter-Hausner Intl. 1
- Ascep, Inc. 1
- American V. Mueller 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220920 | Matreneu Percutaneous Balloon Compression KitHAO · Traditional | Shenzhen Shineyard Medical Device Co. , Ltd. | 09/07/2022SE |
| K940973 | Mullan Ganglion Microcompression SetHAO · Traditional | Cook, Inc. | 09/29/1995SE |
| K951492 | Rib ResectorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 05/18/1995SE |
| K943115 | Auto Suture Pituitary Spinal RongeurHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/25/1994SE |
| K942971 | Auto Suture Spinal DissectorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942970 | Auto Suture Spinal ElevatorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942969 | Auto Suture Spinal Nerve HookHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942968 | Auto Suture Spinal OsteotomeHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942967 | Auto Suture Spinal CuretteHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K923723 | Silicone Brain Spatula SetHAO · Traditional | Redmond Neurosurgical, Inc. | 08/12/1992SE |
| K910226 | Dural DissectorsHAO · Traditional | Acra Cut, Inc. | 02/12/1991SE |
| K910225 | Bone Pad RemoverHAO · Traditional | Acra Cut, Inc. | 02/12/1991SE |
| K902850 | Zeppelin InstrumentsHAO · Traditional | Ruggles Corp. | 07/18/1990SE |
| K892546 | Taylor Spinal RetractorHAO · Traditional | Zinnanti Surgical Instruments, Inc. | 05/11/1989SE |
| K882422 | Disposable Arachnoid KnifeHAO · Traditional | Microbio-Medics, Inc. | 09/06/1988SE |
| K880278 | Malleable PTFE Coated Brain SpatulaeHAO · Traditional | Downs Surgical , Ltd. | 02/11/1988SE |
| K874962 | Forceps Cliprack Ventricular Cannula Saws SpatulasHAO · Traditional | Solway, Inc. | 02/02/1988SE |
| K874630 | Range of Titanium Neurosurgery InstrumentsHAO · Traditional | Downs Surgical , Ltd. | 12/23/1987SE |
| K863416 | Raylor Mini-ProbeHAO · Traditional | Cedar Surgical, Inc. | 09/24/1986SE |
| K863415 | Raylor Bone ImpactorsHAO · Traditional | Cedar Surgical, Inc. | 09/24/1986SE |
| K862331 | Fujitsu Malleable - Tip Brain SpatulaHAO · Traditional | Downs Surgical , Ltd. | 07/01/1986SE |
| K861630 | Neurosurgical Insturments (Various)HAO · Traditional | Downs Surgical , Ltd. | 05/09/1986SE |
| K832343 | Dermaland Dural HooksHAO · Traditional | National Fabtronix, Inc. | 08/12/1983SE |
| K822048 | H-H Nerve Root RetractorHAO · Traditional | Holter-Hausner Intl. | 07/22/1982SE |
| K821357 | Modified Neuro Surgery Nibbling ForcepsHAO · Traditional | Downs Surgical , Ltd. | 05/14/1982SE |
| K802726 | Instruments Nonsterile & SterileHAO · Traditional | Ascep, Inc. | 11/19/1980SE |
| K801760 | Field-Lee Brain Biopsy NeedleHAO · Traditional | American V. Mueller | 09/09/1980SE |
| K780579 | Subcupass Tunneling ToolHAO · Traditional | Medtronic Vascular | 05/19/1978SE |
| K780520 | Vas ApproximatorHAO · Traditional | Edward Weck, Inc. | 05/16/1978SE |
| K772389 | Dandy Hemostatic ForcepsHAO · Traditional | Edward Weck, Inc. | 01/06/1978SE |
| K772371 | Bayonet Surgical InstrumentsHAO · Traditional | Edward Weck, Inc. | 01/06/1978SE |
| K772013 | Percupass Tunneling Tool Model 3452HAO · Traditional | Medtronic Vascular | 10/28/1977SE |
| K761097 | Vanderbilt Blade HolderHAO · Traditional | Codman & Shurtleff, Inc. | 11/30/1976SE |
| K761095 | Vanderbilt CuretteHAO · Traditional | Codman & Shurtleff, Inc. | 11/30/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2705-2011 | Sequoia final driver closure top retention, non-sterile, REF 3384-2, Zimmer Spine…A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock… | Zimmer Inc. | 04/04/2011Terminated |
| Z-2425-2010 | Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use…Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions. | Integra LifeSciences Corp | 07/02/2010Terminated |