# K190813: CrossBay Cervical Dilator Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Crossbay Medical
- Decided: Aug 23, 2019 after 147 days
- Product code: PON (Catheter, Balloon, Dilation Of Cervical Canal)
- Device class: 2
- Regulation: 21 CFR 884.4260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K021012 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160664: Aqueduct 100 Cervical Dilator, Gtimd, LLC (2016) Summary page 4.

## Indications for use
The CrossBay™ Cervical Dilator Catheter System is intended to be used whenever cervical softening and dilation is desired. Some examples are: • Treatment of cervical stenosis • IUD placement and removal • Placement of instruments for intrauterine radiotherapy • Endometrial biopsy • Global endometrial ablation • Uterine tissue removal • Uterine curettage • Diagnostic hysteroscopy • Operative hysteroscopy This device is not intended for use in the induction of labor.

Source page: https://510kreport.com/device/K190813
Methodology: https://510kreport.com/methodology