Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope, Model IN0431; Colonoscope, Model IN0432
FDA 510(k) K073484 · Ethicon Endo-Surgery, Inc.
510(k) numberK073484
Submission
- Device name
- Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope, Model IN0431; Colonoscope, Model IN0432
- Applicant
- Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US - Received
- December 11, 2007
- Decision date
- March 10, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODC – Endoscope Channel Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To give the endoscope channel additional or improved functionality.
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Questions and answers
When was Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope, Model IN0431; Colonoscope, Model IN0432 cleared by the FDA?
Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope, Model IN0431; Colonoscope, Model IN0432 (K073484) received a 510(k) decision of Substantially Equivalent on March 10, 2008, 90 days after the submission was received.
What is the product code of K073484?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.