510(k) K232486

KARL STORZ Monopolar Resectoscopes with HF Cable by Karl Storz SE & CO. KG — Product Code FJL

K232486 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "KARL STORZ Monopolar Resectoscopes with HF Cable". The FDA issued a decision of Substantially Equivalent on May 7, 2024. The device falls under product code FJL (Resectoscope), a Class II device regulated under 21 CFR 876.1500. Karl Storz SE & CO. KG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2024
Date Received
August 16, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resectoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type