Last synced on 9 December 2022 at 11:04 pm

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 Im

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210052
510(k) Type
Traditional
Applicant
Saneso Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/1/2022
Days to Decision
448 days
Submission Type
Summary

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 Im

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210052
510(k) Type
Traditional
Applicant
Saneso Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/1/2022
Days to Decision
448 days
Submission Type
Summary