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Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243535
510(k) Type
Special
Applicant
Shanghai SeeGen Photoelectric Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
3/7/2025
Days to Decision
112 days
Submission Type
Summary

Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243535
510(k) Type
Special
Applicant
Shanghai SeeGen Photoelectric Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
3/7/2025
Days to Decision
112 days
Submission Type
Summary