510(k) K261706

Endomat Select (UP220) by KARL STORZ SE & CO. KG — Product Code HIG

K261706 is an FDA 510(k) premarket notification submitted by KARL STORZ SE & CO. KG for the device "Endomat Select (UP220)". The FDA issued a decision of Substantially Equivalent on July 16, 2026. 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 16, 2026
Date Received
May 22, 2026
Clearance Type
Traditional
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