510(k) · Cleared
Cleared3D Surgical Endoscopy System for Urology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · FCG Biopsy Needle
Cleared on Dec 20, 1995 after a 530-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 211 devices in its family, counting itself, have a Class I recall. 210 later devices descend from it.
- Decided
- Dec 20, 1995
- Review
- 530 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 0
210 later devices descend from it, 2 citing it directly. 4 of the 211 devices in this family, counting this one, have a Class I recall.
- This deviceK943304 3D Surgical Endoscopy System for UrologyOlympus America, Inc. · 1995
- Descendant · cites it directly · 175 of its ownK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- Descendant · 2 generations on · 157 of its ownK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- Descendant · 3 generations on · 154 of its ownK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 80 of its ownK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 5 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
Showing 5 of 210 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 210 · See all- K981993Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998 · cites it directly175descendants
- K994231Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000 · 2 generations on157descendants
- K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · 3 generations on154descendants
- K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · 4 generations on80descendants
- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 5 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943304 | 3D Surgical Endoscopy System for Urology | Olympus America, Inc. | 1995 | — |
| +1 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| +2 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| +3 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| +4 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +5 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 7 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 9 | 0 |
| 2016 | 14 | 1 |
| 2017 | 7 | 2 |
| 2018 | 12 | 0 |
| 2019 | 9 | 0 |
| 2020 | 17 | 1 |
| 2021 | 11 | 0 |
| 2022 | 12 | 0 |
| 2023 | 9 | 0 |
| 2024 | 11 | 0 |
| 2025 | 20 | 0 |
| 2026 | 13 | 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.
4 devices in this family have a Class I recall. 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 FCG device
- #1 K250994 ClearTip FNA and FNB Typesscore 13.2 · 12 generations · 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? (210)
See all 2102 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 9 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 9 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 10 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 11 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- Of its descendants, K981993 (The Olympus Optical Co., 1998) has gone furthest, with 175 descendants of its own.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCG
82in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FCG
5in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCG
632in 2025
MAUDE reports naming product code FCG, 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 | 4 | 32 | 0 | 11 |
| 2008 | 1 | — | 19 | 115 |
| 2009 | 4 | 87 | 5 | 270 |
| 2010 | 3 | 18 | 4 | 73 |
| 2011 | 1 | — | 2 | 71 |
| 2012 | 0 | — | 0 | 107 |
| 2013 | 1 | — | 0 | 130 |
| 2014 | 5 | 88 | 0 | 154 |
| 2015 | 4 | 91 | 0 | 124 |
| 2016 | 3 | 63 | 0 | 191 |
| 2017 | 3 | 166 | 0 | 273 |
| 2018 | 6 | 140 | 0 | 282 |
| 2019 | 0 | — | 0 | 229 |
| 2020 | 1 | — | 0 | 240 |
| 2021 | 1 | — | 5 | 290 |
| 2022 | 2 | — | 0 | 302 |
| 2023 | 4 | 82 | 0 | 428 |
| 2024 | 1 | — | 0 | 446 |
| 2025 | 2 | — | 0 | 632 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K943304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943304: 3D Surgical Endoscopy System for Urology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943304
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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