510(k) · Cleared
ClearedOES Elite Ureteroscopes and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Aug 28, 2020 as substantially equivalent to K052044 (Acmi Corporation, 2005) and 1 other predicate after a 196-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Aug 28, 2020
- Review
- 196 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011849 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK011849 Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633…Circon Video · 2001
- 1 generation backK052044 Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALAcmi Corporation · 2005
- This deviceK200369 OES Elite Ureteroscopes and AccessoriesOlympus Winter & Ibe GmbH · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011849 | Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642)… | Circon Video | 2001 | — |
| −1 | K052044 | Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6AL | Acmi Corporation | 2005 | — |
| 0 (this device) | K200369 | OES Elite Ureteroscopes and Accessories | Olympus Winter & Ibe GmbH | 2020 | — |
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 FGB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FGB device
- #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K052044 | Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALSummary page 4…uct Code: FGB ■ Product Code Name: Ureteroscope and Accessories, Flexible/Rigid ■ Regulatory Class: II 3. Predicate Devices K052044, ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes K011849, MRO-742A Ureteroscope No reference devices were used in this submission.… | 2005 |
| * | K011849 | Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642) Ureteroscopes…Summary page 4…Ureteroscope and Accessories, Flexible/Rigid ■ Regulatory Class: II 3. Predicate Devices K052044, ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes K011849, MRO-742A Ureteroscope No reference devices were used in this submission.… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K052044.
How does its category compare?
All FGB devicesFGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FGB
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGB
134in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGB
15in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGB
1,307in 2025
MAUDE reports naming product code FGB, 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 | 6 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 142 |
| 2018 | 4 | 191 | 0 | 118 |
| 2019 | 2 | — | 0 | 207 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 3 | 191 | 0 | 325 |
| 2022 | 5 | 205 | 4 | 455 |
| 2023 | 8 | 183 | 1 | 458 |
| 2024 | 16 | 217 | 15 | 572 |
| 2025 | 17 | 134 | 0 | 1,307 |
| 2026 | 9 | 140 | 1 | — |
What is it indicated for?
The Olympus ureteroscopes can be utilized for endoscopic observation and therapy in the ureters, urethra, and urinary bladder. Semi-rigid optical instrument for the visualization of the following diagnostic and therapeutic procedures: - Transurethral inspection of the ureters and renal pelvis for diagnosis - Transurethral insertion of catheters, guide wires, cannulas, forceps, electrodes, baskets, lithotripsy probes and laser fibres into the ureter -…
Read the full statement (120 words)
The Olympus ureteroscopes can be utilized for endoscopic observation and therapy in the ureters, urethra, and urinary bladder.
Semi-rigid optical instrument for the visualization of the following diagnostic and therapeutic procedures:
- Transurethral inspection of the ureters and renal pelvis for diagnosis
- Transurethral insertion of catheters, guide wires, cannulas, forceps, electrodes, baskets, lithotripsy probes and laser fibres into the ureter
- Transurethral treatment and removal of tissue, catheters, guide wires, debris and stones from urethra, urinary bladder and ureters
- Transurethral treatment and removal of tissue and stones from the ureters and renal pelvis.
The products are not intended for treatment of infants. For children (>2 years) and adults, refer to the particular constitution and anatomy of the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200369 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200369: OES Elite Ureteroscopes and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200369
Report an extraction error
Are you the manufacturer?
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