Endo-Ease Endoscopic Overtube
FDA 510(k) K060235 · Spirus Medical, Inc.
510(k) numberK060235
Submission
- Device name
- Endo-Ease Endoscopic Overtube
- Applicant
- Spirus Medical, Inc.
Ayer, MA, US - Received
- January 30, 2006
- Decision date
- August 4, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDA – Enteroscope And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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More from Fujifilm Medical Systems U.S.A, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K080050 | Spirus Medical Endo-Ease Endoscopic OvertubeFED · Traditional | 05/06/2008SE |
| K080042 | Spirus Medical Surgical InstrumentKMJ · Traditional | 04/03/2008SE |
| K062805 | Modification to Endo-EaseFED · Special | 10/13/2006SE |
| K052084 | Endo-Ease Endoscopic OvertubeFED · Traditional | 09/14/2005SE |
Questions and answers
When was Endo-Ease Endoscopic Overtube cleared by the FDA?
Endo-Ease Endoscopic Overtube (K060235) received a 510(k) decision of Substantially Equivalent on August 4, 2006, 186 days after the submission was received.
What is the product code of K060235?
The FDA product code is FDA – Enteroscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.