Encircle Localization Device
FDA 510(k) K022286 · Vivant Medical, Inc.
510(k) numberK022286
Submission
- Device name
- Encircle Localization Device
- Applicant
- Vivant Medical, Inc.
Mountain View, CA, US - Received
- July 15, 2002
- Decision date
- October 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Encircle Localization Device cleared by the FDA?
Encircle Localization Device (K022286) received a 510(k) decision of Substantially Equivalent on October 11, 2002, 88 days after the submission was received.
What is the product code of K022286?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.