# K963580: Imagyn Falloposcopy System

- Pathway: 510(k) (Traditional)
- Applicant: Imagyn Medical, Inc.
- Decided: Jan 31, 1997 after 147 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) Baxter Healthcare Corp. LE PTA Catheter: named in the summary without a submission number
- (no number) Conceptus Fallopian Tube Catheterization System: named in the summary without a submission number
- (no number) OvaMed GyneSys Dx Uterine Ostial Access Catheter: named in the summary without a submission number
- (no number) OvaMed Saratoga Modular Miniature Endoscope System: named in the summary without a submission number
- (no number) Optimed Technologies, Inc. Flexible Fiber Optic Hysteroscopes: named in the summary without a submission number

## Indications for use
The Imagyn Falloposcopy System is indicated for intratubal, catheterization for evaluation of occlusions in the fallopian tube. e

Source page: https://510kreport.com/device/K963580
Methodology: https://510kreport.com/methodology