Machida Flexible Neuro-Endoscope, Models NEU-4, NEU-4L
FDA 510(k) K993568 · Machida Endoscope Co., Ltd.
510(k) numberK993568
Submission
- Device name
- Machida Flexible Neuro-Endoscope, Models NEU-4, NEU-4L
- Applicant
- Machida Endoscope Co., Ltd.
Tokyo, JP - Received
- October 21, 1999
- Decision date
- March 13, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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).
Other 510(k)s with product code GWG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253602 | Precision S 4K SinuscopeGWG · Traditional | Stryker Endoscopy | 06/04/2026SE |
| K253679 | Hydro Irrigation SystemGWG · Traditional | Stryker Instruments | 05/08/2026SE |
| 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 |
Questions and answers
When was Machida Flexible Neuro-Endoscope, Models NEU-4, NEU-4L cleared by the FDA?
Machida Flexible Neuro-Endoscope, Models NEU-4, NEU-4L (K993568) received a 510(k) decision of Substantially Equivalent on March 13, 2000, 144 days after the submission was received.
What is the product code of K993568?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.