# K992655: Fertiloscopy Kit FH 1.29/Fto 1.40

- Pathway: 510(k) (Traditional)
- Applicant: Soprane S.A.
- Decided: Mar 13, 2000 after 217 days
- Product code: HEW (Culdoscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1640
- 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) Circon Corporation’s Transvaginal Hydro® Laparoscopy (THL™) System: named in the summary without a submission number
- (no number) Cook OB/GYN’s Intrauterine Balloon Access Catheter (IBA Catheter): named in the summary without a submission number
- (no number) Imagyn Medical, Inc.’s MicroSpan Hysteroscope Sheath (MicroSpan): named in the summary without a submission number
- (no number) Origin Medsystems, Inc.’s Blunt Tip Trocar: named in the summary without a submission number

## Indications for use
The Fertiloscopy Kit is intended to be used for transvaginal hydro-laparoscopy, dye-test, salpingoscopy, and hysteroscopy during one procedure. The device is indicated for use in the diagnosis of tubo-peritoneal infertility.

Source page: https://510kreport.com/device/K992655
Methodology: https://510kreport.com/methodology