510(k) K043128
K043128 is an FDA 510(k) premarket notification submitted by Olympus Corporation for the device "OLYMPUS ENDOARM". The FDA issued a decision of Substantially Equivalent on December 21, 2004. The device falls under product code GWG (Endoscope, Neurological), a Class II device regulated under 21 CFR 882.1480. Olympus Corporation has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2004
- Date Received
- November 12, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Endoscope, Neurological
- Device Class
- Class II
- Regulation Number
- 882.1480
- Review Panel
- NE
- Submission Type
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).