510(k) K253020

Strauss Surgical Resection Instruments by American Medical Endoscopy, Inc. — Product Code HIH

K253020 is an FDA 510(k) premarket notification submitted by American Medical Endoscopy, Inc. for the device "Strauss Surgical Resection Instruments". The FDA issued a decision of Substantially Equivalent on June 4, 2026. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. American Medical Endoscopy, Inc. has at least 2 other 510(k) clearances on record.