# K853216: Master Endomet Biopsy Kit W/Plas Cure 3,4MM-4003,4

- Pathway: 510(k) (Traditional)
- Applicant: Gyneco, Inc.
- Decided: Apr 2, 1986 after 244 days
- Product code: HHK (Curette, Suction, Endometrial (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1175
- 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 has not posted a summary or statement for it, so its predicates are not known.

Source page: https://510kreport.com/device/K853216
Methodology: https://510kreport.com/methodology