510(k) K223885

HOPKINS Telescopes by Karl Storz Endoscopy America, Inc. — Product Code HIH

K223885 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy America, Inc. for the device "HOPKINS Telescopes". The FDA issued a decision of Substantially Equivalent on September 14, 2023. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Karl Storz Endoscopy America, Inc. has at least 10 other 510(k) clearances on record.