510(k) · Cleared
ClearedOlympus FG Series Grasping Forceps
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 Jan 25, 1996 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Jan 25, 1996
- Review
- 80 days
- Class
- Class II
- Product code
- OCZ
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK955066 Olympus FG Series Grasping ForcepsOlympus America, Inc. · 1996
- Descendant · cites it directly · 14 of its ownK160766 Ambu USR, Ambu MAmbu A/S · 2016
- Descendant · 2 generations on · 13 of its ownK193095 Ambu aScope 4 CystoAmbu A/S · 2020
- Descendant · cites it directly · 2 of its ownK962533 Olypus FG Series Grasping ForcepsOlympus America, Inc. · 1996
- Descendant · 3 generations on · 1 of its ownK222162 Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU…Shanghai AnQing Medical Instrument Co., Ltd. · 2022
- Descendant · 3 generations on · 1 of its ownK222602 Pusen Single Use Flexible Video Cystoscope System (Single Use…Zhuhai Pusen Medical Technology Co., Ltd. · 2022
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K160766Ambu USR, Ambu MAmbu A/S · 2016 · cites it directly14descendants
- K193095Ambu aScope 4 CystoAmbu A/S · 2020 · 2 generations on13descendants
- K962533Olypus FG Series Grasping ForcepsOlympus America, Inc. · 1996 · cites it directly2descendants
- K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd. · 2022 · 3 generations on1descendant
- K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope…Zhuhai Pusen Medical Technology Co., Ltd. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955066 | Olympus FG Series Grasping Forceps | Olympus America, Inc. | 1996 | — |
| +1 | K160766 | Ambu USR, Ambu M | Ambu A/S | 2016 | — |
| +2 | K193095 | Ambu aScope 4 Cysto | Ambu A/S | 2020 | — |
| +1 | K962533 | Olypus FG Series Grasping Forceps | Olympus America, Inc. | 1996 | — |
| +3 | K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022 | — |
| +3 | K222602 | Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video… | Zhuhai Pusen Medical Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 182 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?
- Of its descendants, K160766 (Ambu A/S, 2016) has gone furthest, with 14 descendants of its own.
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 | — |
https://510kreport.com/device/K955066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955066: Olympus FG Series Grasping Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955066
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026