510(k) K993568
K993568 is an FDA 510(k) premarket notification submitted by Machida Endoscope Co., Ltd. for the device "MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L". The FDA issued a decision of Substantially Equivalent on Mar 13, 2000. The device falls under product code GWG (Endoscope, Neurological), a Class II device regulated under 21 CFR 882.1480.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 13, 2000
- Date Received
- Oct 21, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Endoscope, Neurological
- Device Class
- Class II
- Regulation Number
- 882.1480
- Review Panel
- NE
- Submission Type
- 510(k)
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).