510(k) K173070
K173070 is an FDA 510(k) premarket notification submitted by Henke-Sass, Wolf GmbH for the device "HSW Resection Instruments". The FDA issued a decision of Substantially Equivalent on June 8, 2018. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Henke-Sass, Wolf GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2018
- Date Received
- September 29, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hysteroscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type