# K993699: The Stripper

- Pathway: 510(k) (Traditional)
- Applicant: Mid-Atlantic Diagnostics, Inc.
- Decided: May 16, 2000 after 196 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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.

## Most influential descendants
- K161275: EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip (2017), 2 descendants of its own
- K250838: Denudation Pipettes (2025), 0 descendants of its own
- K192146: V-Denupet (2020), 0 descendants of its own
- K150748: Flexipet Denuding Pipette, Flexipet Manipulation Pipette (2015), 0 descendants of its own

## Indications for use
“THE STRIPPER®” MICROPIPET FAMILY’S INDICATION FOR USE IS T0 MANIPULATE AND TRANSFER ZYGOTES AND EMBRYOS DURING IVF AND ICSI PROCEDURES. “THE STRIPPER®” MICROPIPETS ARE USED IN THE TISSUE CULTURE TECHNIQUES PERFORMED BY EMBRYOLOGISTS WHEN PREPARING OOCYTES FOR IVF, ICSI AND ASSISTED HATCHING TECHNIQUES PRIOR TO RE-IMPLANTATION. “THE STRIPPER®” MICROPIPETS ARE TOOLS USED IN PROCEDURES THAT HAVE BEEN DEVELOPED TO AID INFERTILE COUPLES ACHIEVE PREGNANCY. REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE FOR CONFIRMATION OF FERTILITY DURING IVF. REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE PRIOR TO ICSI PROCEDURES. USED TO TRANSFER EMBRYOS AND OOCYTES THROUGH VARIOUS MEDIA AND SOLUTIONS DURING THE IVF PROCEDURE.

Source page: https://510kreport.com/device/K993699
Methodology: https://510kreport.com/methodology