# K073484: Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope, Model IN0431; Colonoscope, Model IN0432

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Mar 10, 2008 after 90 days
- Product code: ODC (Endoscope Channel Accessory)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011016 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024301: Lsi Endoscopic External Accessory Channel and Accessories Product, Lsi Solutions (2003) Summary page 4.
- K040836: Disposable Overtube, United States Endoscopy Group, Inc. (2004). 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”.
- (no number) Olympus Splinting Tube, ST-C4: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K073484
Methodology: https://510kreport.com/methodology