510(k) K210052
K210052 is an FDA 510(k) premarket notification submitted by Saneso, Inc. for the device "Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))". The FDA issued a decision of Substantially Equivalent on April 1, 2022. The device falls under product code FDF (Colonoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Saneso, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2022
- Date Received
- January 8, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colonoscope And Accessories, Flexible/Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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).