# K092421: Alphahysteroscope, Fiberoptic, Operative and Diagnostic

- Pathway: 510(k) (Abbreviated)
- Applicant: Gimmi GmbH
- Decided: Feb 12, 2010 after 189 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
Longest line of descent: 1 generation back to K972426 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972426: Microspan Gold Hysteroscope and Microspan Hysteroscope Sheath, Imagyn Medical, Inc. (1997) Summary page 7.
- K012869: Gimmi Alpha Hysteroscopes & Accessories, Models E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25, Gimmi GmbH (2002) Summary page 2.

## Indications for use
AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures.

Source page: https://510kreport.com/device/K092421
Methodology: https://510kreport.com/methodology