# K260314: Ancora-SB

- Pathway: 510(k) (Traditional)
- Applicant: Aspero Medical, Inc.
- Decided: May 1, 2026 after 91 days
- Product code: FDA (Enteroscope And Accessories)
- 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: 8 generations back to K993704 (2000). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231323: Ancora-SB, Aspero Medical, Inc. (2023) Summary page 5.

## Indications for use
The Ancora-SB is an accessory to an endoscope. The Ancora-SB is intended for use with any standard endoscope that has an outer diameter of 9.0-9.4 mm and a working length of 1680 mm or greater. The Ancora-SB is intended for use with any standard flexible endoscopy balloon inflation unit with a set pressure of 5.4 kPa (+2.6 kPa, -1.8 kPa). The device is indicated to ensure complete positioning of an endoscope in the small intestine by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment.

Source page: https://510kreport.com/device/K260314
Methodology: https://510kreport.com/methodology