# K013972: H/S Elliptosphere Catheter Set, Model 61-4005

- Pathway: 510(k) (Special)
- Applicant: Ackard Laboratories
- Decided: Dec 17, 2001 after 14 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953034 (1995). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961752: H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607), Ackrad Laboratories (1996) Summary page 1.

## Most influential descendants
- K083594: EZ HSG Catheter.Foamseal Catheter (2009), 2 descendants of its own
- K180300: Margolin HSG Cannula, Goldstein Sonohysterography Catheter (2018), 1 descendant of its own
- K222798: Rejoni Intrauterine Catheter (2022), 0 descendants of its own
- K063611: Saline/ Contrast Media Infusion Catheter (2007), 0 descendants of its own
- K021272: Sib Catheter, Model 61-7005 (2002), 0 descendants of its own

## Recalls of this device
- Mar 31, 2022 · Class II · Z-0503-2024: Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
- Mar 31, 2022 · Class II · Z-0504-2024: Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

## Indications for use
The H/S Elliptosphere Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.

Source page: https://510kreport.com/device/K013972
Methodology: https://510kreport.com/methodology