Alphahysteroscope, Fiberoptic, Operative and Diagnostic
FDA 510(k) K092421 · Gimmi GmbH
510(k) numberK092421
Submission
- Device name
- Alphahysteroscope, Fiberoptic, Operative and Diagnostic
- Applicant
- Gimmi GmbH
Saint Paul, MN, US - Received
- August 7, 2009
- Decision date
- February 12, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIH – Hysteroscope (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1690
- Specialty
- Obstetrics/Gynecology
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| K254251 | InnovexView (GC146-17, GC150-20, GC155-23)HIH · Traditional | Shanghai AnQing Medical Instrument Co., Ltd. | 02/26/2026SE |
| K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope…HIH · Traditional | Jiangsu Jiyuan Medical Technology Co., Ltd. | 12/18/2025SE |
| K252012 | SPY Cystoscope/HysteroscopeHIH · Special | Stryker Endoscopy | 07/18/2025SE |
| K243382 | RZ Resectoscope SystemHIH · Traditional | Rz Medizintechnik GmbH | 06/03/2025SE |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…HIH · Traditional | MacroLux Medical Technology Co., Ltd. | 08/16/2024SE |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)HIH · Special | Guangzhou Red Pine Medical Instrument Co., Ltd. | 08/02/2024SE |
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| K081640 | Gimmi Aneurysm Clips and Applying ForcepsHCH · Abbreviated | 05/06/2009SE |
| K012869 | Gimmi Alpha Hysteroscopes & Accessories, Models E.8XXX.XX, T.8XXX.XX, Zxxx.Xx,S.Xxxx.Xx…HIH · Abbreviated | 03/11/2002SE |
| K012660 | Gimmi'Alpha' Endoscopes & AccessoriesFET · Abbreviated | 12/20/2001SE |
| K013731 | Gimmi Alpha Sinuscopes Model # E.8282.01/31/71 + E.8284.01/31/71; Gimmi Alpha…EOQ · Traditional | 11/27/2001SE |
Questions and answers
When was Alphahysteroscope, Fiberoptic, Operative and Diagnostic cleared by the FDA?
Alphahysteroscope, Fiberoptic, Operative and Diagnostic (K092421) received a 510(k) decision of Substantially Equivalent on February 12, 2010, 189 days after the submission was received.
What is the product code of K092421?
The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.