ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC— 510(k) K092421

Clearance details

Applicant

Gimmi GmbH

Product code

Code HIH

Device class

Class 2

Regulation

21 CFR 884.1690

Advisory panel

Obstetrics/Gynecology

Date received

2009-08-07

Decision date

2010-02-12

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Saint Paul, MN, US

• K254294 — Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)2026-09-08
• K260984 — HERizon RD5 Resecting Device (5FR1PK); HERizon RD5 Resecting Device - 5 pack (5FR5PK)2026-08-18
• K253020 — Strauss Surgical Resection Instruments2026-06-04
• K254050 — Manual Tissue Removal Device2026-05-15
• K254251 — InnovexView (GC146-17, GC150-20, GC155-23)2026-02-26

• K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22
• K093125 — ALPHAXENON LIGHT 180 W AND 300 W2010-01-27
• K081640 — GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS2009-05-06
• K012869 — GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.252002-03-11
• K012660 — GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES2001-12-20

Death

18

Injury

973

Malfunction

5,071

Other

1

Total

6,063

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →