# K974801: Single Channel Balloon Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Conkin Surgical Instruments, Ltd.
- Decided: Jul 9, 1998 after 199 days
- Product code: HDP (Elevator, 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SINGLE CHANNEL BALLOON CANNULA is to be used with the VALTCHEV UTERINE MOBILIZER, models VUM-4 or VUM-5, for mobilization of the uterus and injection of dye. It is indicated for use during those procedures requiring manipulation of the uterus such as a minilap, laparoscopic tubal occlusion or diagnostic and operative laparoscopy. It is also an efficient intrauterine injector that effectively seals the internal cervical os against the cervical backflow of fluid during its injection through the device’s central lumen and as such can be used in laparoscopic tubal patency studies and, in selected patients, for such procedures as hysterosalpingography.

Source page: https://510kreport.com/device/K974801
Methodology: https://510kreport.com/methodology