510(k) · Cleared
ClearedOES ELITE Telescopes, Protective Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · FBP Telescope, Rigid, Endoscopic
Cleared on Nov 24, 2015 as substantially equivalent to K923982 (Olympus Corp., 1993) after a 204-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Nov 24, 2015
- Review
- 204 days
- Class
- Class II
- Product code
- FBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923982 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK923982 Olympus Oes Laparoscopy SystemOlympus Corp. · 1993 · Recalled
- This deviceK151191 OES ELITE Telescopes, Protective TubeOlympus Winter & Ibe GmbH · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923982 | Olympus Oes Laparoscopy System | Olympus Corp. | 1993 | 1 |
| 0 (this device) | K151191 | OES ELITE Telescopes, Protective Tube | Olympus Winter & Ibe GmbH | 2015 | — |
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 FBP? 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 |
|---|---|---|---|
| * | K923982 | Olympus Oes Laparoscopy SystemSummary page 5…K151191 Pg. 2 of 4 3. Predicate device K923982, Olympus OES Laparoscopy System 4. Description of device The OES ELITE Telescopes are rigid endoscopes. An image relay sys… | 1993 |
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?
- Its one ancestor has a recall.
- 4 other devices also cite its predicate K923982.
How does its category compare?
All FBP devicesFBP Telescope, Rigid, Endoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · FBP
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · FBP
Too few FBP 510(k)s in any year since 2007 to give a median.
Recalls per year · FBP
No recall names FBP since 2007.
Adverse event reports per year · FBP
2in 2024
MAUDE reports naming product code FBP, 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 | 7 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 1 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OES Elite Telescopes are indicated to provide the user with the means for visualizing diagnostic and therapeutic surgical procedures. The device is intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151191: OES ELITE Telescopes, Protective Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151191
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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