# K021166: Acmi Bipolar Rectoscope, Model Eiwe-BR

- Pathway: 510(k) (Special)
- Applicant: Acmi-Circon Corporation
- Decided: May 9, 2002 after 28 days
- Product code: FDC (Resectoscope, Working Element)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951972 (1995). 1 ancestor in all.
4 later devices descend from it; 1 cites 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)
- K951972: Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic Sheaths, Cabot Medical Corp. (1995) Summary page 1.

## Most influential descendants
- K031001: Acmi Vista CTR Bipolar Loop Electrode (2003), 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

## Indications for use
intended for use in patients requiring endoscopic surgery for general urological tissue resection, ablation, and excision and hemostasis of blood vessels. These procedures include Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resectioh, and Treatment of Vesical Neck Constriction.

Source page: https://510kreport.com/device/K021166
Methodology: https://510kreport.com/methodology