Merit Bipolar Coagulation Probe
FDA 510(k) K102273 · Merit Medical Systems, Inc.
510(k) numberK102273
Submission
- Device name
- Merit Bipolar Coagulation Probe
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- August 11, 2010
- Decision date
- September 7, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Merit Bipolar Coagulation Probe cleared by the FDA?
Merit Bipolar Coagulation Probe (K102273) received a 510(k) decision of Substantially Equivalent on September 7, 2010, 27 days after the submission was received.
What is the product code of K102273?
The FDA product code is KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.4300.