510(k) · Cleared
ClearedEndo Optiks Urological Catheter for Endoscopy, Model Sessr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endooptiks, Inc. · EYB Catheter, Ureteral, Gastro-Urology
Cleared on Mar 3, 2009 as substantially equivalent to K022135 (Boston Scientific Corp, 2002) and 1 other predicate after a 74-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Mar 3, 2009
- Review
- 74 days
- Class
- Class II
- Product code
- EYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K022135 (2002). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK022135 Ureteral Access Sheath Set (Uass)Boston Scientific Corp · 2002
- This deviceK083788 Endo Optiks Urological Catheter for Endoscopy, Model SessrEndooptiks, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022135 | Ureteral Access Sheath Set (Uass) | Boston Scientific Corp | 2002 | — |
| 0 (this device) | K083788 | Endo Optiks Urological Catheter for Endoscopy, Model Sessr | Endooptiks, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 EYB? 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 EYB device
- #1 K192183 RocaTub Ureteral Catheterscore -0.2 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K022135 | Ureteral Access Sheath Set (Uass)Summary page 1…. e-mail: [email protected] DEVICE COMMON NAME: Urolog‘cal Catheter and Accessories PREDICATE DEVICE: * Boston Scientific Corporation UASS Ureteral Access Sheath K022135 (CFR 21 part 876.5130, Urological Catheter and Accessories) * Bard Dual Lumen Ureteral Catheter K032521 - 4 (CFR 21 part 876.5130… | 2002 |
| * | K032521 | Bard Dual Lumen Ureteral CatheterSummary page 1…ICE: * Boston Scientific Corporation UASS Ureteral Access Sheath K022135 (CFR 21 part 876.5130, Urological Catheter and Accessories) * Bard Dual Lumen Ureteral Catheter K032521 - 4 (CFR 21 part 876.5130, Urological Catheter and Acocessories) ~ DEVICE DESCRIPTION The Stonebuster Endoscopic System for Sto… | 2003 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K022135.
How does its category compare?
All EYB devicesEYB Catheter, Ureteral, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EYB
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · EYB
248in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EYB
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EYB
11in 2025
MAUDE reports naming product code EYB, 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 | 14 |
| 2008 | 0 | — | 1 | 15 |
| 2009 | 1 | — | 0 | 42 |
| 2010 | 1 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 2 | — | 0 | 8 |
| 2019 | 3 | 248 | 0 | 22 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 1 | 5 |
| 2023 | 0 | — | 0 | 23 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Stonebuster Endoscopic System for Stone Removal (SESSR) Catheter for Endoscopy is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as biopsy forceps, cytology brushes, stone retrieval baskets, etc. during endoscopic procedures.
The indications for use of the catheter are in urological applications.
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/K083788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083788: Endo Optiks Urological Catheter for Endoscopy, Model Sessr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083788
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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