The following data is part of a premarket notification filed by Henke-sass, Wolf Gmbh with the FDA for 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.
| Device ID | K171336 |
| 510k Number | K171336 |
| Device Name: | 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 |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | Henke-Sass, Wolf GmbH Keltenstrasse 1 Tuttlingen, DE 78532 |
| Contact | Anna Reifschneider |
| Correspondent | Anna Reifschneider Henke-Sass, Wolf GmbH Keltenstrasse 1 Tuttlingen, DE 78532 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-08 |
| Decision Date | 2017-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810143890518 | K171336 | 000 |
| 00810143890990 | K171336 | 000 |
| 00810143890983 | K171336 | 000 |
| 00810143890976 | K171336 | 000 |
| 00810143890969 | K171336 | 000 |
| 00810143890952 | K171336 | 000 |
| 00810143890945 | K171336 | 000 |
| 00810143890938 | K171336 | 000 |