510(k) K183262
K183262 is an FDA 510(k) premarket notification submitted by Lucid Diagnostics, Inc. for the device "EsoCheck CCD Cell Collection Device". The FDA issued a decision of Substantially Equivalent (kit) on June 21, 2019. The device falls under product code EOX (Esophagoscope (Flexible Or Rigid)), a Class II device regulated under 21 CFR 874.4710. Lucid Diagnostics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- June 21, 2019
- Date Received
- November 23, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Esophagoscope (Flexible Or Rigid)
- Device Class
- Class II
- Regulation Number
- 874.4710
- Review Panel
- EN
- 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).