Naviaid Bge Device, Model 21-001
FDA 510(k) K060923 · Smart Medical Systems , Ltd.
510(k) numberK060923
Submission
- Device name
- Naviaid Bge Device, Model 21-001
- Applicant
- Smart Medical Systems , Ltd.
Kfar Saba, IL - Received
- April 4, 2006
- Decision date
- August 15, 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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Questions and answers
When was Naviaid Bge Device, Model 21-001 cleared by the FDA?
Naviaid Bge Device, Model 21-001 (K060923) received a 510(k) decision of Substantially Equivalent on August 15, 2006, 133 days after the submission was received.
What is the product code of K060923?
The FDA product code is FDA – Enteroscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.