510(k) K190719
K190719 is an FDA 510(k) premarket notification submitted by Penumbra, Inc. for the device "Artemis Eye System". The FDA issued a decision of Substantially Equivalent on August 30, 2019. The device falls under product code GWG (Endoscope, Neurological), a Class II device regulated under 21 CFR 882.1480. Penumbra, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2019
- Date Received
- March 20, 2019
- 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
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).