# K990913: Hoc Set with Valve, Hoc Set Without Valve, Hoc Set with Valve - Soft Plug, Hoc Set Without Valve - Soft Plug, Ops Withou

- Pathway: 510(k) (Traditional)
- Applicant: Laboratoires Prodimed
- Decided: Jun 8, 1999 after 82 days
- Product code: MQE (Needle, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6100
- 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
These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.

Source page: https://510kreport.com/device/K990913
Methodology: https://510kreport.com/methodology