510(k) · Cleared
ClearedOlympus FG Series of Rat Tooth Grasping Forceps (Urology)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · FBO Cystourethroscope
Cleared on Dec 20, 1996 as substantially equivalent to K955051 (Olympus America, Inc., 1996) after a 178-day review. Its family tree reaches back 1 generation to 1996. 9 later devices descend from it.
- Decided
- Dec 20, 1996
- Review
- 178 days
- Class
- Class II
- Product code
- FBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955051 (1996). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955051 Olympus FG Series of Rat Tooth Grasping ForcepsOlympus America, Inc. · 1996
- This deviceK962474 Olympus FG Series of Rat Tooth Grasping Forceps (Urology)Olympus America, Inc. · 1996
- Descendant · cites it directly · 5 of its ownK061276 G-Prox Endoscopic GrasperUsgi Medical · 2006
- Descendant · cites it directly · 2 of its ownK061268 G-Lix Tissue GrasperUsgi Medical · 2006
- Descendant · 2 generations on · 1 of its ownK100251 G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333Usgi Medical · 2010
- Descendant · 2 generations on · 1 of its ownK093018 G-Prox Endoscopic Grasper, Model 205333Usgi Medical · 2009
- Descendant · 2 generations on · 1 of its ownK080051 Virtual Ports Endoclear SystemVirtual Ports, Ltd. · 2008
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K061276G-Prox Endoscopic GrasperUsgi Medical · 2006 · cites it directly5descendants
- K061268G-Lix Tissue GrasperUsgi Medical · 2006 · cites it directly2descendants
- K100251G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333Usgi Medical · 2010 · 2 generations on1descendant
- K093018G-Prox Endoscopic Grasper, Model 205333Usgi Medical · 2009 · 2 generations on1descendant
- K080051Virtual Ports Endoclear SystemVirtual Ports, Ltd. · 2008 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955051 | Olympus FG Series of Rat Tooth Grasping Forceps | Olympus America, Inc. | 1996 | — |
| 0 (this device) | K962474 | Olympus FG Series of Rat Tooth Grasping Forceps (Urology) | Olympus America, Inc. | 1996 | — |
| +1 | K061276 | G-Prox Endoscopic Grasper | Usgi Medical | 2006 | — |
| +1 | K061268 | G-Lix Tissue Grasper | Usgi Medical | 2006 | — |
| +2 | K100251 | G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333 | Usgi Medical | 2010 | — |
| +2 | K093018 | G-Prox Endoscopic Grasper, Model 205333 | Usgi Medical | 2009 | — |
| +2 | K080051 | Virtual Ports Endoclear System | Virtual Ports, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 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 FBO? 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 FBO device
- #1 K244001 KARL STORZ Cysto-Urethro-Fiberscope…score 9.3 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K955051 | Olympus FG Series of Rat Tooth Grasping ForcepsSummary page 1…ing Forceps Endoscope and Accessories 21 CFR 876.1500, Class i Olympus Pre-Amendment and 5§10(k) cleared grasping forceps Olympus FG-Series Rat tooth Grasping Forceps (K955051) Barry Sands Olympus America, Inc. Endoscope Division 2 Corporate Center Drive Melville, NY 11747-3157 (516) 844-5474 June 17… | 1996 |
| * | — | Olympus Pre-Amendment grasping forceps Named without a submission number |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 FBO devicesFBO Cystourethroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FBO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBO
Too few FBO 510(k)s in any year since 2007 to give a median.
Recalls per year · FBO
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FBO
26in 2025
MAUDE reports naming product code FBO, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 1 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 0 | — | 5 | 33 |
| 2023 | 0 | — | 1 | 29 |
| 2024 | 1 | — | 0 | 30 |
| 2025 | 1 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Olympus FG-6/7/8/9/42/47-1 grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body, and excised tissue 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/K962474 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962474: Olympus FG Series of Rat Tooth Grasping Forceps (Urology).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962474
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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