Lina Bipolar Loop; Standard Size, Large Size, Extra Large Size
FDA 510(k) K130305 · Lina Medical Aps
510(k) numberK130305
Submission
- Device name
- Lina Bipolar Loop; Standard Size, Large Size, Extra Large Size
- Applicant
- Lina Medical Aps
Austin, TX, US - Received
- February 5, 2013
- Decision date
- July 24, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIN – Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4150
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Lina Bipolar Loop; Standard Size, Large Size, Extra Large Size cleared by the FDA?
Lina Bipolar Loop; Standard Size, Large Size, Extra Large Size (K130305) received a 510(k) decision of Substantially Equivalent on July 24, 2013, 169 days after the submission was received.
What is the product code of K130305?
The FDA product code is HIN – Coagulator-Cutter, Endoscopic, Bipolar (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4150.