510(k) · Cleared
ClearedAcmi Bipolar Rectoscope, Model Eiwe-BR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acmi-Circon Corporation · FDC Resectoscope, Working Element
Cleared on May 9, 2002 as substantially equivalent to K951972 (Cabot Medical Corp., 1995) after a 28-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- May 9, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- FDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951972 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK951972 Cabot Medical Ultra Flow Cystourethroscope System with Operating &…Cabot Medical Corp. · 1995
- This deviceK021166 Acmi Bipolar Rectoscope, Model Eiwe-BRAcmi-Circon Corporation · 2002
- Descendant · cites it directly · 3 of its ownK031001 Acmi Vista CTR Bipolar Loop ElectrodeAcmi Corporation · 2003
- Descendant · 2 generations on · 2 of its ownK062720 S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp. · 2007 · Recalled
- Descendant · 3 generations on · 1 of its ownK191341 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion…Corinth Medtech, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK250522 Multi4 SystemMulti4 Medical AB · 2025
Most influential descendants
Showing 4 of 4 · See all- K031001Acmi Vista CTR Bipolar Loop ElectrodeAcmi Corporation · 2003 · cites it directly3descendants
- K062720S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp. · 2007 · 2 generations on2descendants
- K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc. · 2019 · 3 generations on1descendant
- K250522Multi4 SystemMulti4 Medical AB · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951972 | Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic… | Cabot Medical Corp. | 1995 | — |
| 0 (this device) | K021166 | Acmi Bipolar Rectoscope, Model Eiwe-BR | Acmi-Circon Corporation | 2002 | — |
| +1 | K031001 | Acmi Vista CTR Bipolar Loop Electrode | Acmi Corporation | 2003 | — |
| +2 | K062720 | S-Line Bipolar Resectoscopes and Bipolar Electrodes | Richard Wolf Medical Instruments Corp. | 2007 | 2 |
| +3 | K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope… | Corinth Medtech, Inc. | 2019 | — |
| +4 | K250522 | Multi4 System | Multi4 Medical AB | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FDC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951972 | Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic SheathsSummary page 1…00) Trade Name: ACMI USA Elite Series Bipolar Resectoscope Generic/Common Name: Endoscope and accessories Predicate Devices ACMI USA Elite Resectoscope Preamendment & K951972 with Monopolar Working Element Inténded Uses lntcjénded for use in patients requiring endoscopic surgery for general urological… | 1995 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031001 | Acmi Vista CTR Bipolar Loop Electrode | 2003 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FDC devicesFDC Resectoscope, Working Element: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDC
FDA has decided no FDC device since 2007.
Median 510(k) review, days · FDC
Too few FDC 510(k)s in any year since 2007 to give a median.
Recalls per year · FDC
No recall names FDC since 2007.
Adverse event reports per year · FDC
19in 2025
MAUDE reports naming product code FDC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 15 |
| 2008 | 0 | — | 0 | 19 |
| 2009 | 0 | — | 0 | 13 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 27 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 0 | — | 0 | 29 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 19 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021166 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021166: Acmi Bipolar Rectoscope, Model Eiwe-BR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021166
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026