# K202427: Aqueduct 100 Plus Cervical Dilation Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Gtimd, LLC
- Decided: Nov 6, 2020 after 73 days
- Product code: PON (Catheter, Balloon, Dilation Of Cervical Canal)
- Device class: 2
- Regulation: 21 CFR 884.4260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K021012 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160664: Aqueduct 100 Cervical Dilator, Gtimd, LLC (2016) Summary page 4.

## Indications for use
The Aqueduct 100 Plus Cervical Dilation Balloon Catheter is intended to be used whenever cervical softening and dilation is desired. Some examples are: treatment of cervical stenosis, IUD placement and removal, Radium placement, drainage of uterine cavity, endometrial biopsy, uterine curettage, suction cannula aspiration, operative hysteroscopy.

Source page: https://510kreport.com/device/K202427
Methodology: https://510kreport.com/methodology