# K083690: Femvue (TM) Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Femasys, Inc.
- Decided: Jun 23, 2009 after 193 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 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) Ackrad H/S Catheter Set: named in the summary without a submission number
- (no number) AngioTech/MD Tech PBN Fallopian Tube Catheter System: named in the summary without a submission number
- (no number) Ackrad IUI Set for Intrauterine Insemination: named in the summary without a submission number
- (no number) Stargate Falloposcopy Catheter: named in the summary without a submission number
- (no number) Trifurcated Irrigation Tubing: named in the summary without a submission number

## Most influential descendants
- K123258: The Advance Catheter for HSG and Sis (2013), 3 descendants of its own
- K160217: uVue HSG/SHG Catheter (2016), 1 descendant of its own
- K181770: Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (2019), 0 descendants of its own
- K180291: Cook Silicone Balloon HSG Catheter (2018), 0 descendants of its own
- K142545: SonoFlow Sonohysterography and Sonohysterosalpingography Device (2015), 0 descendants of its own

## Indications for use
The FemVue TM Catheter System is intended for the delivery of contrast media during hysterosalpingogram (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency.

Source page: https://510kreport.com/device/K083690
Methodology: https://510kreport.com/methodology