# K964955: Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands Encap+/Guidewire (Regular Shaft/Stiff Shaft) NO Marking

- Pathway: 510(k) (Traditional)
- Applicant: Flexmedics
- Decided: Feb 14, 1997 after 65 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 K931650 (1993). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931650: Microvasive Insurg Geenen CBD Guide Wire, Boston Scientific Corp (1993) Summary page 1.
- K942074: Flexfinder Guidewire, Flexmedics (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K910597: Sunglasses Model #SP Promo #1 and SP Promo #2, Radix Group Intl. (1991). Our OCR of the scanned summary read K910597, FDA’s number for Sunglasses Model #SP Promo #1 and SP Promo #2 (Radix Group Intl.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Protector Plus Guidewire”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K023603: Endo-Glide Guidewire (2003), 2 descendants of its own
- K051068: Zutron Colonoscope Stiffening Device (2005), 1 descendant of its own
- K251204: FUJIFILM Stiffening Wire Device (SW-2000) (2025), 0 descendants of its own
- K012556: Reprocessed Guidewires (2002), 0 descendants of its own

## Indications for use
The FlexFinder® Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The FlexFinder® Guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.

Source page: https://510kreport.com/device/K964955
Methodology: https://510kreport.com/methodology