# K950166: Olympus KD-6G1-9Q Wire Guided Papillotomu Knife

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Feb 22, 1995 after 36 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K011149: Disposable Bending Cannula PR-233Q (2001), 12 descendants of its own
- K051504: Spyscope Access and Delivery Catheter (2005), 11 descendants of its own
- K090170: Spyscope Access and Delivery Catheter (2009), 10 descendants of its own
- K142922: SpyGlass DS Direct Visualization System (2015), 9 descendants of its own
- K181439: SpyGlass DS and DS II Direct Visualization System (2018), 7 descendants of its own

## Recalls of this device
- Jan 7, 2026 · Class II · Z-1292-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1290-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1294-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1295-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1293-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1287-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1289-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1296-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1288-2026: Devices which did not undergo thermoforming could deform and lose performance.
- Jan 7, 2026 · Class II · Z-1291-2026: Devices which did not undergo thermoforming could deform and lose performance.

Source page: https://510kreport.com/device/K950166
Methodology: https://510kreport.com/methodology