# K983587: Hysteroscopic Gift Catheter Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Dec 16, 1998 after 64 days
- Product code: MQF (Catheter, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6110
- 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 its predicate without a number.
- (no number) Lee Hysteroscopic Intrafallopian Transfer Catheter: named in the summary without a submission number

## Indications for use
The Hysteroscopic GIFT Catheter Sets are used to transfer gametes directly into the fallopian tube via hysteroscopic guidance. These catheters and sets are intended for one time use and will be marketed sterile.

Source page: https://510kreport.com/device/K983587
Methodology: https://510kreport.com/methodology