# K932114: Tubal Lumen Support

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Sep 27, 1994 after 512 days
- Product code: HFJ (Prosthesis, Fallopian Tube)
- Device class: 2
- Regulation: 21 CFR 884.3650
- 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. The FDA summary names no predicate by number.

## Indications for use
The Tubal Lumen Support is used for maintaining patency of and providing support to the fallopian tube during an anastomosis procedure.

Source page: https://510kreport.com/device/K932114
Methodology: https://510kreport.com/methodology