510(k) · Cleared
ClearedInstruments for Endoscopic Subfascial Harvesting of Veins (Eshv), Instruments for Endoscopic Subfascial Discision of Per
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 Aug 27, 1998 as substantially equivalent to K964258 (Richard Wolf Medical Instruments Corp., 1997) after a 315-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Aug 27, 1998
- Review
- 315 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964258 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964258 Instruments for Endoscopic Subfascial Discision of Perforating Vins…Richard Wolf Medical Instruments Corp. · 1997
- This deviceK973943 Instruments for Endoscopic Subfascial Harvesting of Veins (Eshv)…Richard Wolf Medical Instruments Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964258 | Instruments for Endoscopic Subfascial Discision of Perforating Vins Esdp… | Richard Wolf Medical Instruments Corp. | 1997 | — |
| 0 (this device) | K973943 | Instruments for Endoscopic Subfascial Harvesting of Veins (Eshv), Instruments… | Richard Wolf Medical Instruments Corp. | 1998 | — |
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? (1)
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 |
|---|---|---|---|
| * | K964258 | Instruments for Endoscopic Subfascial Discision of Perforating Vins Esdp, Model 8781Summary page 1…Classification Name: Operating Tubes. Operating Telescope Endoscopes and Accessories Laser Guide. Knife 510(k) Number Trade or proprietary or model name Manufacturer 1 K964258 1 Instruments for Endoscopic Subfascial Discision of 1 Richard Wolf Perforating Veins “ESDP”. Model 8781 2 2 See section 3, Equi… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K964258.
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 ESHV (Endoscopic Subfascial Harvesting of Veins) instrument set is used for minimally invasive preparation and harvesting of the veins for use in cardiac and vascular surgical procedures. The intervention takes place under sterile conditions. The Veins dissector (stripper) is used for the blunt preparation of tubular structures, specifically for the free-preparation of vessels, e.g. the vein saphena magma. The ESDP (Endoscopic Subfascial Discision of…
Read the full statement (97 words)
The ESHV (Endoscopic Subfascial Harvesting of Veins) instrument set is used for
minimally invasive preparation and harvesting of the veins for use in cardiac and vascular
surgical procedures. The intervention takes place under sterile conditions.
The Veins dissector (stripper) is used for the blunt preparation of tubular structures,
specifically for the free-preparation of vessels, e.g. the vein saphena magma.
The ESDP (Endoscopic Subfascial Discision of Perforating Veins) instrument set is used
for minimally invasive visualization, diagnostic, and therapeutic procedures of subfascial
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/K973943 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973943: Instruments for Endoscopic Subfascial Harvesting of Veins (Eshv), Instruments for Endoscopic Subfascial Discision of Per.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973943
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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