The following data is part of a premarket notification filed by Henke-sass, Wolf Gmbh with the FDA for Hsw Resection Instruments.
| Device ID | K173070 |
| 510k Number | K173070 |
| Device Name: | HSW Resection Instruments |
| Classification | Hysteroscope (and Accessories) |
| 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 | HIH |
| Subsequent Product Code | FAJ |
| Subsequent Product Code | FAS |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810143890846 | K173070 | 000 |
| 00810143891003 | K173070 | 000 |
| 00810143891010 | K173070 | 000 |
| 00810143891027 | K173070 | 000 |
| 00810143890853 | K173070 | 000 |
| 00810143890860 | K173070 | 000 |
| 00810143890709 | K173070 | 000 |
| 00810143890716 | K173070 | 000 |
| 00810143890747 | K173070 | 000 |
| 00810143890754 | K173070 | 000 |
| 00810143890761 | K173070 | 000 |
| 00810143890778 | K173070 | 000 |
| 00810143890785 | K173070 | 000 |
| 00810143890792 | K173070 | 000 |
| 00810143890808 | K173070 | 000 |
| 00810143890815 | K173070 | 000 |
| 00810143890822 | K173070 | 000 |
| 00810143890839 | K173070 | 000 |
| 00810143890877 | K173070 | 000 |