# K012869: Gimmi Alpha Hysteroscopes & Accessories, Models E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25

- Pathway: 510(k) (Abbreviated)
- Applicant: Gimmi GmbH
- Decided: Mar 11, 2002 after 196 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- 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. Our reading found no predicate number; beside “510(k)” the summary reads “012249”, which our checks could not confirm as its predicate.
- (no number) Giinter Bissinger Medizintechnik: named in the summary without a submission number
- (no number) Comeg Endoscopy: named in the summary without a submission number
- (no number) Dufner Instrumente GmbH: named in the summary without a submission number
- (no number) Henke-Sass Wolf, GmbH: named in the summary without a submission number
- (no number) Optus, Inc.: named in the summary without a submission number
- (no number) Pilling Weck Group: named in the summary without a submission number
- (no number) Wolf: named in the summary without a submission number
- (no number) Karl Storz Endoscopy: named in the summary without a submission number

## Most influential descendants
- K092421: Alphahysteroscope, Fiberoptic, Operative and Diagnostic (2010), 0 descendants of its own

## Indications for use
GIMMI ALPHA® Hysteroscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. These generic devices are used to perform diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K012869
Methodology: https://510kreport.com/methodology