Last synced on 2 December 2022 at 11:04 pm

Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171336
510(k) Type
Traditional
Applicant
Henke-Sass, Wolf GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
12/7/2017
Days to Decision
213 days
Submission Type
Summary

Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171336
510(k) Type
Traditional
Applicant
Henke-Sass, Wolf GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
12/7/2017
Days to Decision
213 days
Submission Type
Summary