Smith & Nephew Vascular Videoendoscope System, Model 7209273
FDA 510(k) K012724 · Smith & Nephew, Inc.
510(k) numberK012724
Submission
- Device name
- Smith & Nephew Vascular Videoendoscope System, Model 7209273
- Applicant
- Smith & Nephew, Inc.
Andover, MA, US - Received
- August 14, 2001
- Decision date
- November 8, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYK – Angioscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Smith & Nephew Vascular Videoendoscope System, Model 7209273 cleared by the FDA?
Smith & Nephew Vascular Videoendoscope System, Model 7209273 (K012724) received a 510(k) decision of Substantially Equivalent on November 8, 2001, 86 days after the submission was received.
What is the product code of K012724?
The FDA product code is LYK – Angioscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.