# K974819: Selectcells (TM) Mini

- Pathway: 510(k) (Traditional)
- Applicant: Select Medical Systems, Inc.
- Decided: Mar 23, 1998 after 90 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 its predicate without a number.
- (no number) Pipelle®: named in the summary without a submission number

## Most influential descendants
- K102847: Disposable Endometrial Suction Curette (2011), 0 descendants of its own

## Indications for use
Biopsy to obtain a sample for histologic evaluation of the endometrium (uterine mucosal lining) or sample extraction of the uterine menstrual content for: - Evaluation of infertility conditions, menstrual disorders, postmenopausal bleeding, abnormal cytology suggesting endometrial origin, hormonal replacement therapy (HRT); - Detection of endometrial carcinoma (Please note: The most reliable method for the detection of endometrial carcinoma is dilation of the cervix and uterine curettage performed under general anesthesia); - Evaluation of luteal defect (Evaluation of luteal defect is visually determined histologically from endometrial tissue obtained only during the secretory [progestational] phase of the menstrual cycle); - Endometrial dating; - Microscopic examination; - and, this device is useful for patients presenting a narrow cervix or cervical canal and in postmenopausal women whose cervix might be narrower with any of the indications listed above. However, because of its smaller diameter, it should be recognized that the amount (quantity) of sample obtained with this device will be reduced.

Source page: https://510kreport.com/device/K974819
Methodology: https://510kreport.com/methodology