510(k) · Cleared
ClearedEndopath Ultra-Retractor/ Endopath Vessel Dissector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Nov 13, 1997 after an 84-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Nov 13, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK973139 Endopath Ultra-Retractor/ Endopath Vessel DissectorEthicon Endo-Surgery, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK022989 Radlite Tissue Retractor SystemGenzyme Biosurgery · 2002
- Descendant · cites it directly · 0 of its ownK013576 Pericscope, Model # PERISC1Ethicon Endo-Surgery, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK012724 Smith & Nephew Vascular Videoendoscope System, Model 7209273Smith & Nephew, Inc. · 2001
Most influential descendants
Showing 3 of 3 · See all- K022989Radlite Tissue Retractor SystemGenzyme Biosurgery · 2002 · cites it directly0descendants
- K013576Pericscope, Model # PERISC1Ethicon Endo-Surgery, Inc. · 2002 · cites it directly0descendants
- K012724Smith & Nephew Vascular Videoendoscope System, Model 7209273Smith & Nephew, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973139 | Endopath Ultra-Retractor/ Endopath Vessel Dissector | Ethicon Endo-Surgery, Inc. | 1997 | — |
| +1 | K022989 | Radlite Tissue Retractor System | Genzyme Biosurgery | 2002 | — |
| +1 | K013576 | Pericscope, Model # PERISC1 | Ethicon Endo-Surgery, Inc. | 2002 | — |
| +1 | K012724 | Smith & Nephew Vascular Videoendoscope System, Model 7209273 | Smith & Nephew, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 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 GCJ? 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?
The FDA summary names no predicate by number.
What descends from it? (3)
3 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, K022989 (Genzyme Biosurgery, 2002) has gone furthest, with 0 descendants of its own.
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 ENDOPATH® Ultra-Retractor has application for the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in all types of surgical procedures requiring dissection and retraction of tissue.
The Vessel Dissector has application for use in the blunt dissection of tubular structures such as veins, arteries, nerves and ducts. The device may also be used in all types of surgical procedures requiring dissection of tissue.
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/K973139 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973139: Endopath Ultra-Retractor/ Endopath Vessel Dissector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973139
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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