510(k) · Cleared
ClearedEthicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope, Model IN0431; Colonoscope, Model IN0432
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · ODC Endoscope Channel Accessory
Cleared on Mar 10, 2008 as substantially equivalent to K024301 (Lsi Solutions, 2003) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Mar 10, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011016 (2001). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK011016 Lsi Solutions Flexible Suture Placement Device and Accessories ProductLsi Solutions · 2001 · Recalled
- 1 generation backK024301 Lsi Endoscopic External Accessory Channel and Accessories ProductLsi Solutions · 2003
- This deviceK073484 Ethicon Endo Surgery Sheath and Articulating Accessory Channel -…Ethicon Endo-Surgery, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011016 | Lsi Solutions Flexible Suture Placement Device and Accessories Product | Lsi Solutions | 2001 | 1 |
| −1 | K024301 | Lsi Endoscopic External Accessory Channel and Accessories Product | Lsi Solutions | 2003 | — |
| 0 (this device) | K073484 | Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope… | Ethicon Endo-Surgery, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 ODC? 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 ODC device
- #1 K232329 Defendo Fujifilm 700 Single Use Biopsy Valve…score 14.1 · 6 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 |
|---|---|---|---|
| * | K024301 | Lsi Endoscopic External Accessory Channel and Accessories ProductSummary page 4…Accessories Classification Name: Endoscopes and accessories [21 CFR 876.1500 (KOG)] Predicate Devices LSI Endoscopic External Accessory Channel and Accessories Product (K024301) US Endoscopy Disposable Overtube (K040835) Olympus Splinting Tube, ST-C4 (510(k) unknown). Indications for Use The Ethicon En… | 2003 |
| * | K040836 | Disposable Overtube Our OCR of the scanned summary read K040835, FDA’s number for Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and… (Pm Devices, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “US Endoscopy Disposable Overtube”. | 2004 |
| * | — | Olympus Splinting Tube, ST-C4 Named without a submission number |
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K024301.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ODC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODC
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODC
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODC
91in 2025
MAUDE reports naming product code ODC, 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 | 0 | — | 0 | 0 |
| 2008 | 3 | 83 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 67 | 0 | 0 |
| 2011 | 4 | 143 | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 4 | 55 | 0 | 40 |
| 2020 | 4 | 128 | 0 | 54 |
| 2021 | 6 | 181 | 0 | 52 |
| 2022 | 8 | 118 | 0 | 37 |
| 2023 | 7 | 126 | 0 | 43 |
| 2024 | 8 | 95 | 0 | 100 |
| 2025 | 6 | 106 | 0 | 91 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Ethicon Endo Surgery® Sheath and Articulating External Accessory Channel accessory product is intended for use as a supplemental conduit that attaches to an endoscope to enable improved access.
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/K073484 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073484: Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope, Model IN0431; Colonoscope, Model IN0432.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073484
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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