# OCY: Endoscopic Guidewire, Gastroenterology-Urology

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) exempt
- FDA decisions: 43
- Recalls: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2005: 1
- 2006: 2
- 2007: 1
- 2008: 3
- 2009: 1
- 2012: 2
- 2013: 4
- 2014: 5
- 2015: 3
- 2016: 1

## Most-cited predicates
- K040137: Wilson-Cook Usw Cap and Wire Lock (2004), cited by 4
- K011759: Radius Next Generation Guidewire (2001), cited by 2
- K931650: Microvasive Insurg Geenen CBD Guide Wire (1993), cited by 2
- K910722: 450CM Guide Wire for G.I. Use (1991), cited by 2
- K964955: Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands Encap+/Guidewire (Regular Shaft/Stiff Shaft) NO Marking (1997), cited by 2
- K910497: Wilson Cook Wire Guide and Protective Guide (1991), cited by 2
- K021179: Disposable Guidewire, Models G-205-3545S & G-205-3545A (2002), cited by 2
- K943737: Microvasive Pathfinder Exchange Guidewire Insurg Pathfinder Guidewire (1994), cited by 2
- K122816: Axcess Soft Tip Wire Guide (2012), cited by 2
- K081708: Taxi Endoscopic Guidewire (2008), cited by 2

Source page: https://510kreport.com/product-code/OCY
Data by year (CSV): https://510kreport.com/product-code/OCY.csv