# K973500: Bard Endoscopic Overtube (#000307)

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 16, 1997 after 30 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- 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
No predicates in its family tree.
32 later devices descend from it; 5 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard Endoscopic Overtube: named in the summary without a submission number
- (no number) Olympus Splinting Tube ST-C3: named in the summary without a submission number

## Most influential descendants
- K002018: Ndo Surgical Surgical Overtube (2000), 20 descendants of its own
- K052084: Endo-Ease Endoscopic Overtube (2005), 18 descendants of its own
- K023902: Shape-Lockable Endoscopic Overtube (2003), 17 descendants of its own
- K033954: Shape Locking Endoscopic Overtube (2004), 16 descendants of its own
- K052930: Navigator Endoscopy System (2006), 13 descendants of its own

## Indications for use
To be used with an endoscope when repeated endoscopic intubation is anticipated, e.g., esophageal ligation, change of endoscopes, removal of multiple polyps and/or foreign bodies.

Source page: https://510kreport.com/device/K973500
Methodology: https://510kreport.com/methodology