# K802458: Kevorkian-Younge Biopsy Curette #90-6611

- Pathway: 510(k) (Traditional)
- Applicant: J. Sklar Mfg. Co., Inc.
- Decided: Jan 12, 1981 after 96 days
- Product code: HFB (Forceps, Biopsy, Gynecological)
- Device class: 1
- Regulation: 21 CFR 884.4530
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Dec 3, 2024 · Class II · Z-0943-2025: Reports of various packaging issues that may result in a breach of the sterile barrier.

Source page: https://510kreport.com/device/K802458
Methodology: https://510kreport.com/methodology