510(k) · Cleared
ClearedOlympus Subcutaneous Endoscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Dec 31, 1996 as substantially equivalent to K950076 (Olympus America, Inc., 1995) and 2 other predicates after a 139-day review. Its family tree reaches back 1 generation to 1995. 4 of the 182 devices in its family, counting itself, have a Class I recall. 178 later devices descend from it.
- Decided
- Dec 31, 1996
- Review
- 139 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K950076 (1995). 3 ancestors in all. 178 later devices descend from it, 3 citing it directly. 4 of the 182 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK950076 LaparoscopeOlympus America, Inc. · 1995
- This deviceK963184 Olympus Subcutaneous Endoscopy SystemOlympus America, Inc. · 1996
- 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 178 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 178 · 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 |
|---|---|---|---|---|---|
| −1 | K950076 | Laparoscope | Olympus America, Inc. | 1995 | — |
| 0 (this device) | K963184 | Olympus Subcutaneous Endoscopy System | Olympus America, Inc. | 1996 | — |
| +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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 11 | 0 |
| 2014 | 11 | 0 |
| 2015 | 7 | 0 |
| 2016 | 14 | 1 |
| 2017 | 6 | 2 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 13 | 1 |
| 2021 | 9 | 0 |
| 2022 | 10 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 13 | 0 |
| 2026 | 9 | 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.
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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K950076 | LaparoscopeSummary page 1…on Name: Endoscope and Accessories Predicate Devices: Olympus Endoscopes for Subcutaneous Dissection/Resection in Plastic/Reconstructive Surgery and Aesthetic Surgery (K950076); Olympus Hand Instruments for Subcutaneous Dissection/Resection in Plastic/Reconstructive Surgery and Aesthetic Surgery (K950103… | 1995 |
| * | K950103 | Laparoscope, Hand InstrumentsSummary page 1…tructive Surgery and Aesthetic Surgery (K950076); Olympus Hand Instruments for Subcutaneous Dissection/Resection in Plastic/Reconstructive Surgery and Aesthetic Surgery (K950103); Ethicon EndoSurgery Hand Retractors, Dissectors for Vessel Harvesting (K955120). Refer to Subsection I-A for additional list of… | 1995 |
| * | K955120 | Hand-Held Retractor, Dissector & DissectorSummary page 1…bcutaneous Dissection/Resection in Plastic/Reconstructive Surgery and Aesthetic Surgery (K950103); Ethicon EndoSurgery Hand Retractors, Dissectors for Vessel Harvesting (K955120). Refer to Subsection I-A for additional list of predicate devices. Submitted By: Mr. Barry Sands (Contact Person) Olympus Ameri… | 1996 |
What descends from it? (178)
See all 1783 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?
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The Olympus Endoscopic Vessel Harvesting System is specifically designed for subcutaneous endoscopy - - more specifically for endoscopically gaining access to, ligating and/or harvesting vessels (e.g. veins, arteries, ducts, nerve) within the subcutaneous and subfacial surgical planes in the lower extremities.
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/K963184 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963184: Olympus Subcutaneous Endoscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963184
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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