# K231323: Ancora-SB

- Pathway: 510(k) (Traditional)
- Applicant: Aspero Medical, Inc.
- Decided: Aug 31, 2023 after 115 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: 7 generations back to K993704 (2000). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071254: Small Intestinal Videoscope System, Olympus Medical Systems Corporation (2008) Summary page 4.
- K221452: DiLumen C1, EZ1 and Tool Mount, Lumendi, LLC (2023) Summary page 4.

## Most influential descendants
- K260314: Ancora-SB (2026), 0 descendants of its own

## 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/K231323
Methodology: https://510kreport.com/methodology