# K160664: Aqueduct 100 Cervical Dilator

- Pathway: 510(k) (Abbreviated)
- Applicant: Gtimd, LLC
- Decided: Aug 1, 2016 after 145 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: 3 generations back to K021012 (2002). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143447: Dilapan-S, Medicem Technology S.R.O (2015) Summary page 4.
- K131206: Cook Cervical Ripening Balloon, Cook, Inc. (2013) Summary page 4.

## Most influential descendants
- K202433: Aqueduct 200 Cervical Dilation Balloon Catheter (2021), 0 descendants of its own
- K202427: Aqueduct 100 Plus Cervical Dilation Balloon Catheter (2020), 0 descendants of its own
- K190813: CrossBay Cervical Dilator Catheter System (2019), 0 descendants of its own

## Indications for use
The Aqueduct 100 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/K160664
Methodology: https://510kreport.com/methodology