510(k) K201355
K201355 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "Endomat Select, IBS Shaver Software, License". The FDA issued a decision of Substantially Equivalent on July 22, 2020. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Karl Storz SE & CO. KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2020
- Date Received
- May 21, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Hysteroscopic
- Device Class
- Class II
- Regulation Number
- 884.1700
- Review Panel
- OB
- Submission Type