ClearanceBrief
510(k) K890328 ยท HIH Hysteroscope (And Accessories)

ADULT RESECTOSCOPE

ApplicantCircon Video, Stanford CT, US
DecisionSubstantially Equivalent, Feb 6, 1990
ReceivedJan 23, 1989
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K890328

DateFirm and productCodeLinked 510(k)
Sep 25, 2026Olympus Corporation of the Americas
Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
Open, Classified		 HIHNone listed
Sep 25, 2026Olympus Corporation of the Americas
Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
Open, Classified		 HIHNone listed
Jul 10, 2026Olympus Corporation of the Americas
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Open, Classified		 KQTNone listed
Jul 21, 2025Olympus Corporation of the Americas
Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen whi
Open, Classified		 HIHNone listed
Jul 21, 2025Olympus Corporation of the Americas
Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some co
Open, Classified		 HIHNone listed
Dec 15, 2023Olympus Corporation of the Americas
ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product p
Open, Classified		 FASNone listed
Apr 17, 2018Gyrus Acmi, Incorporated
Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a gen
Terminated		 FASNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.