Sif-Sw
FDA 510(k) K904800 · Olympus Corp.
510(k) numberK904800
Submission
- Device name
- Sif-Sw
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- October 24, 1990
- Decision date
- March 27, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Sif-Sw cleared by the FDA?
Sif-Sw (K904800) received a 510(k) decision of Substantially Equivalent on March 27, 1991, 154 days after the submission was received.
What is the product code of K904800?
The FDA product code is FDA – Enteroscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.