# K123439: Neo Ercp Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Neometrics, Inc.
- Decided: Jan 3, 2013 after 56 days
- Product code: OCY (Endoscopic Guidewire, 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
Longest line of descent: 1 generation back to K922302 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922302: Jagwire (TM) Recanalization Guidewire, Boston Scientific Corp (1992) Summary page 1.

## Indications for use
The Neo ERCP Guidewire Is Intended for use In selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts and to aid in the placement of diagnostic and therapeutic devices during endloscopic procedures.

Source page: https://510kreport.com/device/K123439
Methodology: https://510kreport.com/methodology