Alphahysteroscope, Fiberoptic, Operative and Diagnostic
FDA 510(k)Class II (US FDA 510(k))
by Gimmi GmbH
Identifiers
- 510(k) Number
- K092421 FDA 510(k)
- FDA Product Code
- HIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1690 FDA 510(k)
- Regulation Number
- 884.1690 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Alphahysteroscope, Fiberoptic, Operative and Diagnostic is a hysteroscope used for both operative and diagnostic procedures in obstetrics and gynecology. It provides access to the uterine cavity when used with hysteroscope sheaths. The device is classified under product code HIH and is intended for medical professionals to perform examinations and procedures within the uterus.
This device is manufactured by Gimmi GmbH and received FDA 510(k) clearance on February 12, 2010, with decision code SESE. It is regulated under 21 CFR 884.1690 for obstetrical and gynecological diagnostic devices. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Frequently asked questions
What is the Alphahysteroscope used for?
The Alphahysteroscope is a fiberoptic device used for both operative and diagnostic procedures in obstetrics and gynecology. It provides access to the uterine cavity when used with compatible hysteroscope sheaths, allowing medical professionals to perform examinations and procedures within the uterus.
Is the Alphahysteroscope single-use or reusable?
The device data does not specify whether the Alphahysteroscope is designed for single-use or reusable applications. This information should be obtained directly from the manufacturer, Gimmi GmbH, or through the product's specific instructions for use.
What regulatory approvals does the Alphahysteroscope have?
The Alphahysteroscope received FDA 510(k) clearance on February 12, 2010, with decision code SESE, indicating it was found substantially equivalent to predicate devices. It is regulated under 21 CFR 884.1690 for obstetrical and gynecological diagnostic devices.
What sizes and models of the Alphahysteroscope are available?
The device data does not provide specific information about available sizes or models of the Alphahysteroscope. Details regarding variations in size, diameter, or specific model numbers should be obtained directly from Gimmi GmbH or through the product's documentation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Alphahysteroscope, Fiberoptic, Operative and Diagnostic (K092421) — Fda ..., Gimmi GmbH FDA 510 (k) Products - Latest 2026, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092421 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (1)
- FDA 510(k) K092421 24 fields · synced Oct 1, 2026