# K890328: Adult Resectoscope

- Pathway: 510(k) (Traditional)
- Applicant: Circon Video
- Decided: Feb 6, 1990 after 379 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022480: Acmi Disposable Bipolar Cord, Model DBC (2002), 3 descendants of its own
- K062720: S-Line Bipolar Resectoscopes and Bipolar Electrodes (2007), 2 descendants of its own
- K191341: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (2019), 1 descendant of its own
- K250522: Multi4 System (2025), 0 descendants of its own
- K031758: Acmi M4 Telescopes (2003), 0 descendants of its own

## Recalls of this device
- Aug 24, 2026 · Class II · Z-3300-2026: There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
- Aug 24, 2026 · Class II · Z-3299-2026: There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
- May 5, 2026 · Class II · Z-2720-2026: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
- Jun 18, 2025 · Class II · Z-2139-2025: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
- Jun 18, 2025 · Class II · Z-2140-2025: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
- Oct 2, 2023 · Class II · Z-0568-2024: Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
- Apr 17, 2018 · Class II · Z-1952-2018: There is a potential for the cord to spark and cause a fire.

Source page: https://510kreport.com/device/K890328
Methodology: https://510kreport.com/methodology