# K041435: The Stripper PGD

- Pathway: 510(k) (Traditional)
- Applicant: Mid-Atlantic Diagnostics, Inc.
- Decided: Sep 29, 2004 after 124 days
- Product code: MQH (Microtools, Assisted Reproduction (Pipettes))
- Device class: 2
- Regulation: 21 CFR 884.6130
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The transfer of the removed blastomere from a holding vessel to a transport vessel. This device is NOT intended for blastomere biopsy from an embryo.

Source page: https://510kreport.com/device/K041435
Methodology: https://510kreport.com/methodology