510(k) · Cleared
ClearedInstruments for Endoscopic Subfascial Discision of Perforating Vins Esdp, Model 8781
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 16, 1997 after an 83-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jan 16, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK964258 Instruments for Endoscopic Subfascial Discision of Perforating Vins…Richard Wolf Medical Instruments Corp. · 1997
- Descendant · cites it directly · 0 of its ownK973943 Instruments for Endoscopic Subfascial Harvesting of Veins (Eshv)…Richard Wolf Medical Instruments Corp. · 1998
- Descendant · cites it directly · 0 of its ownK973232 Olympus Subfascial Endoscopic Perforating Vein Surgery (Seps)…Olympus Winter & Ibe GmbH · 1997
Most influential descendants
Showing 2 of 2 · See all- K973943Instruments for Endoscopic Subfascial Harvesting of Veins (Eshv), Instruments for…Richard Wolf Medical Instruments Corp. · 1998 · cites it directly0descendants
- K973232Olympus Subfascial Endoscopic Perforating Vein Surgery (Seps) System, Its Associated…Olympus Winter & Ibe GmbH · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964258 | Instruments for Endoscopic Subfascial Discision of Perforating Vins Esdp… | Richard Wolf Medical Instruments Corp. | 1997 | — |
| +1 | K973943 | Instruments for Endoscopic Subfascial Harvesting of Veins (Eshv), Instruments… | Richard Wolf Medical Instruments Corp. | 1998 | — |
| +1 | K973232 | Olympus Subfascial Endoscopic Perforating Vein Surgery (Seps) System, Its… | Olympus Winter & Ibe GmbH | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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 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? (8)
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 |
|---|---|---|---|
| * | — | Richard Wolf model 8981.01 Named without a submission number | |
| * | — | Richard Wolf model 8449.20 Named without a submission number | |
| * | — | Richard Wolf model 8960.01 Named without a submission number | |
| * | — | Richard Wolf model 8960.02 Named without a submission number | |
| * | — | Richard Wolf model 8960.03 Named without a submission number | |
| * | — | Richard Wolf model 4937D Named without a submission number | |
| * | — | Richard Wolf model 8383.753 Named without a submission number | |
| * | — | Richard Wolf model 8267.10 Named without a submission number |
What descends from it? (2)
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?
- Of its descendants, K973943 (Richard Wolf Medical Instruments Corp., 1998) 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 “ESDP” instrument set is used for minimally invasive visualization and diagnostic and therapeutic procedures of superficial veins in the lower extremities, e.g. the saphenous vein. The intervention takes place under sterile conditions.
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/K964258 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964258: Instruments for Endoscopic Subfascial Discision of Perforating Vins Esdp, Model 8781.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964258
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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