QEVO System
FDA 510(k) K232159 · Carl Zeiss Meditec, AG
510(k) numberK232159
Submission
- Device name
- QEVO System
- Applicant
- Carl Zeiss Meditec, AG
Oberkochen, DE - Received
- July 20, 2023
- Decision date
- September 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was QEVO System cleared by the FDA?
QEVO System (K232159) received a 510(k) decision of Substantially Equivalent on September 21, 2023, 63 days after the submission was received.
What is the product code of K232159?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.