# K060908: Sonohysterography Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Jun 29, 2006 after 87 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
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. The FDA summary names its predicate without a number.
- (no number) Tampa Catheter: named in the summary without a submission number
- (no number) EZ-HSG Catheter: named in the summary without a submission number
- (no number) Cook Hysterocath: named in the summary without a submission number
- (no number) Goldstein Sonohysterography Catheter: named in the summary without a submission number
- (no number) Probet: named in the summary without a submission number
- (no number) Uterine Explora Model I: named in the summary without a submission number
- (no number) Wallace Suresample Endometrial Sampler: named in the summary without a submission number
- (no number) Pipelle de Cornier Endometrial Suction Curette: named in the summary without a submission number
- (no number) Aspiracath: named in the summary without a submission number

## Most influential descendants
- K133144: Sonosure Sonohysterography & Endometrial Sampling Device (2014), 0 descendants of its own

## Indications for use
The Cook® Sonchysterography Biopsy Catheter is used to access fhe uterine cavily for sonchysterography and to ebtain endometrial biopsy, if indicated, utiiizing the same device. The deviceis a single catheter designed to perform saline infusion sonchysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use.

Source page: https://510kreport.com/device/K060908
Methodology: https://510kreport.com/methodology