510(k) · Cleared
ClearedOlympus Basket Graspers (Urology)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
Cleared on Jul 18, 1996 as substantially equivalent to K955063 (Olympus America, Inc., 1996) after an 84-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jul 18, 1996
- Review
- 84 days
- Class
- Class II
- Product code
- OCZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955063 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955063 Olympus Basket GraspersOlympus America, Inc. · 1996
- This deviceK961611 Olympus Basket Graspers (Urology)Olympus America, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955063 | Olympus Basket Graspers | Olympus America, Inc. | 1996 | — |
| 0 (this device) | K961611 | Olympus Basket Graspers (Urology) | Olympus America, Inc. | 1996 | — |
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 OCZ? 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 OCZ device
- #1 K252800 KARL STORZ Endoscopic Accessories for Urologyscore 11.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K955063 | Olympus Basket GraspersSummary page 1…ology) Basket Graspers Endoscope and Accessories 21 CFR 876.1500, Class I Olympus pre-Amendment and 510(k) cleared graéping forceps Olympus FG Basket Grasper Forceps (K955063) Barry Sands Olympus America, Inc. Medical Instrument Division 2 Corporate Center Drive Melville, NY 11747-3157 (516) 844-5474… | 1996 |
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 no recall.
- 1 other device also cites its predicate K955063.
How does its category compare?
All OCZ devicesOCZ Endoscopic Grasping/Cutting Instrument, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCZ
Too few OCZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OCZ
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCZ
34in 2025
MAUDE reports naming product code OCZ, 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 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 242 |
| 2016 | 1 | — | 0 | 759 |
| 2017 | 0 | — | 0 | 734 |
| 2018 | 0 | — | 0 | 252 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 21 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 17 | 33 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 1 | — | 0 | 37 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Olympus basket graspers are intended to be used to retrieve foreign bodies, excised tissue, etc., endoscopically.
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/K961611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961611: Olympus Basket Graspers (Urology).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961611
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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