# K974028: Stargate Falloposcopy Catheter, Trifurcated Irrigation Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Conceptus, Inc.
- Decided: Jan 21, 1998 after 90 days
- Product code: MKO (Falloposcope)
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Conceptus VS™ Catheter: named in the summary without a submission number
- (no number) Clarus Medical, Model 5150 Tubing Set: named in the summary without a submission number

## Indications for use
The STARRT System is indicated for use as a secondary diagnostic tool for the further evaluation of women previously diagnosed with proximal tubal occlusion by hysterosalpingography or selective salpingography. The STARRT System is only designed to access the proximal portion of the fallopian tube, i.e. the first 2-3 cm. It should only be advanced as far as necessary to achieve a meaningful study, recognizing that possible adverse effects of more distal advancement, particularly upon normal tubes, have not yet been determined. The STARRT System is not intended for tubal recanalization, and there is no data available, in particular, pregnancy data, showing clinical benefit for this use. Studies are underway. The STARRT System is not to be used for gamete or embryo transfer, or other assisted reproduction techniques. The STARRT System should only be used by clinicians with experience in tubal evaluation.

Source page: https://510kreport.com/device/K974028
Methodology: https://510kreport.com/methodology