Cystoscope 4.0mm autoclavable 0° WL 302mm +3 more— 510(k) K171336
Substantially EquivalentHenke-Sass, Wolf GmbH
FDA 510(k) clearance K171336 for Cystoscope 4.0mm autoclavable 0° WL 302mm +3 more, Substantially Equivalent on 2017-12-07. Applicant: Henke-Sass, Wolf GmbH. Device class: 2.
Clearance details
- Device name as filed
- 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
- Applicant
- Henke-Sass, Wolf GmbH
- Product code
- Code FAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tuttlingen, DE
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More clearances from Henke-Sass, Wolf GmbH
view allAdverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.