# K133144: Sonosure Sonohysterography & Endometrial Sampling Device

- Pathway: 510(k) (Traditional)
- Applicant: Crossbay Medical, Inc.
- Decided: Mar 19, 2014 after 153 days
- Product code: PGK (Cannula, Injector, Uterine, Endometrial Biopsy)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K881456 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060908: Sonohysterography Biopsy Device, Cook Urological, Inc. (2006) Summary page 1.
- K082066: Tao Brush I.U.M.C. Endometrial Sampler, Cook Urological, Inc. (2008) Summary page 1.

## Indications for use
The Crosseay SonsoSure Sonohysterography and Endometrial Sampling Device is Indicated for use to access the uterine cavity for saline infusion sonohysterography and to obtain endometrial biopsy, if Indicated, utilizing the same device.

Source page: https://510kreport.com/device/K133144
Methodology: https://510kreport.com/methodology