# K012556: Reprocessed Guidewires

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Apr 29, 2002 after 264 days
- Product code: NML (Catheter, Biliary, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931650 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 5.
- K964955: Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands Encap+/Guidewire (Regular Shaft/Stiff Shaft) NO Marking, Flexmedics (1997) Summary page 5.

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0558-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## Indications for use
Reprocessed guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.

Source page: https://510kreport.com/device/K012556
Methodology: https://510kreport.com/methodology