Ethicon Endo Surgery Articulating Snare
FDA 510(k) K073288 · Ethicon Endo-Surgery, Inc.
510(k) numberK073288
Submission
- Device name
- Ethicon Endo Surgery Articulating Snare
- Applicant
- Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US - Received
- November 21, 2007
- Decision date
- June 12, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDI – Snare, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Ethicon Endo Surgery Articulating Snare cleared by the FDA?
Ethicon Endo Surgery Articulating Snare (K073288) received a 510(k) decision of Substantially Equivalent on June 12, 2008, 204 days after the submission was received.
What is the product code of K073288?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.