# K931476: Novy Cornual Cannulation Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Jul 28, 1995 after 856 days
- Product code: MOV (Catheters, Salpingography)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K180552: Modified Novy Cornual Cannulation Set (2018), 0 descendants of its own

## Recalls of this device
- Apr 15, 2016 · Class II · Z-2621-2016: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading t
- Jan 8, 2010 · Not classified · Z-1138-2010: The distal tip may separate from the catheter while the catheter is in the patient.
- Jan 8, 2010 · Not classified · Z-1137-2010: The distal tip may separate from the catheter while the catheter is in the patient.

Source page: https://510kreport.com/device/K931476
Methodology: https://510kreport.com/methodology