Temno Elite Biopsy System
FDA 510(k) K201166 · Merit Medical Systems, Inc.
510(k) numberK201166
Submission
- Device name
- Temno Elite Biopsy System
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- May 1, 2020
- Decision date
- August 28, 2020
- 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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| K260517 | Automatic Core Biopsy InstrumentKNW · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 08/28/2026SE |
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special | Bard Peripheral Vascular, Inc. | 08/14/2026SE |
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Questions and answers
When was Temno Elite Biopsy System cleared by the FDA?
Temno Elite Biopsy System (K201166) received a 510(k) decision of Substantially Equivalent on August 28, 2020, 119 days after the submission was received.
What is the product code of K201166?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.