Gimmi'Alpha' Endoscopes & Accessories
FDA 510(k) K012660 · Gimmi GmbH
510(k) numberK012660
Submission
- Device name
- Gimmi'Alpha' Endoscopes & Accessories
- Applicant
- Gimmi GmbH
Amsterdam, Nh, NL - Received
- August 13, 2001
- Decision date
- December 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FET – Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
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| K242067 | Visera Elite III Video System Center Olympus OTV-S700; Visera Elite III LED Light Source…FET · Traditional | Olympus Corporations of the Americas | 04/02/2025SE |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F)FET · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 02/07/2025SE |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)FET · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 10/22/2024SE |
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Questions and answers
When was Gimmi'Alpha' Endoscopes & Accessories cleared by the FDA?
Gimmi'Alpha' Endoscopes & Accessories (K012660) received a 510(k) decision of Substantially Equivalent on December 20, 2001, 129 days after the submission was received.
What is the product code of K012660?
The FDA product code is FET – Endoscopic Video Imaging System/Component, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.