rescuenet
FDA 510(k) K152580 · Endochoice, Inc.
510(k) numberK152580
Submission
- Device name
- rescuenet
- Applicant
- Endochoice, Inc.
Alpharetta, GA, US - Received
- September 10, 2015
- Decision date
- November 3, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDI – Snare, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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| K160275 | Fuse Endoscopic System with FuseBox ProcessorPEA · Traditional | 08/01/2016SE |
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| K161167 | Seal Single-Use Biopsy ValveOCX · Special | 05/26/2016SE |
| K160403 | SmartStart Air/Water and Suction ValvesODC · Traditional | 05/19/2016SE |
| K153588 | EndoChoice Water Bottle Cap SystemFEQ · Special | 02/24/2016SE |
| K151475 | EndoChoice Select Injection NeedleFBK · Traditional | 02/08/2016SE |
| K152182 | Fuse Gastroscopy SystemFDS · Special | 12/10/2015SE |
| K142155 | Endochoice Water Bottle Cap SystemFEQ · Traditional | 01/20/2015SE |
| K140472 | Bonastent Tracheal / BronchialJCT · Traditional | 10/17/2014SE |
| K141598 | Fuse Colonoscopy SystemFDF · Special | 09/30/2014SE |
Questions and answers
When was rescuenet cleared by the FDA?
rescuenet (K152580) received a 510(k) decision of Substantially Equivalent on November 3, 2015, 54 days after the submission was received.
What is the product code of K152580?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.