Medtronic PS Medical Murphyscope, Models 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,
FDA 510(k) K010341 · Medtronic PS Medical
510(k) numberK010341
Submission
- Device name
- Medtronic PS Medical Murphyscope, Models 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,
- Applicant
- Medtronic PS Medical
Goleta, CA, US - Received
- February 5, 2001
- Decision date
- April 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GWG – Endoscope, Neurological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1480
- Specialty
- Neurology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K253602 | Precision S 4K SinuscopeGWG · Traditional | Stryker Endoscopy | 06/04/2026SE |
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| K243429 | HJY VisualNext 3D Endoscopic Vision SystemGWG · Traditional | Hjy Smart Medical Device Co., Ltd. | 05/21/2025SE |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG · Special | Integra LifeSciences Corporation | 04/09/2025SE |
| K233391 | cCeLL - In vivoGWG · Traditional | VPIX Medical, Inc. | 08/21/2024SE |
| K223615 | Digital ClarusScope System, Digital NeuroPEN SystemGWG · Traditional | Clarus Medical, LLC | 11/21/2023SE |
| K232618 | Aurora Surgiscope SystemGWG · Traditional | Rebound Therapeutics Corporation | 10/27/2023SE |
| K230125 | Neuroblade SystemGWG · Traditional | Clearmind Biomedical | 10/13/2023SE |
| K232159 | QEVO SystemGWG · Special | Carl Zeiss Meditec, AG | 09/21/2023SE |
| K222735 | HJY VisualNext Endoscopic Vision SystemGWG · Traditional | Hjy Smart Medical Device Co., Ltd. | 07/28/2023SE |
More from Hjy Smart Medical Device Co., Ltd.
| 510(k) | Device | Decision |
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| K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855JXG · Traditional | 02/11/2002SE |
| K010361 | Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900GXR · Traditional | 05/07/2001SE |
| K010487 | Bipolar Pencil, Model 3901-002, 3900-002GEI · Abbreviated | 05/03/2001SE |
| K003914 | Medtronic PS Medical Neuropen Endoscope and Optical AccessoriesGWG · Abbreviated | 02/22/2001SE |
| K002572 | Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003…GWG · Abbreviated | 11/16/2000SE |
| K991502 | Medtronic PS Medical Polyurethane Shunt, Models 27521, 27116, 20022JXG · Traditional | 09/12/2000SE |
| K990333 | Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015GWG · Traditional | 04/28/1999SE |
| K984053 | Becker External Drainage and Monitoring SystemJXG · Traditional | 02/04/1999SE |
| K983799 | Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System…GWM · Traditional | 01/26/1999SE |
| K983331 | Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102HCA · Traditional | 12/16/1998SE |
Questions and answers
When was Medtronic PS Medical Murphyscope, Models 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, cleared by the FDA?
Medtronic PS Medical Murphyscope, Models 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, (K010341) received a 510(k) decision of Substantially Equivalent on April 20, 2001, 74 days after the submission was received.
What is the product code of K010341?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.