Dsnare, Model 00711087
FDA 510(k) K051637 · United States Endoscopy Group, Inc.
510(k) numberK051637
Submission
- Device name
- Dsnare, Model 00711087
- Applicant
- United States Endoscopy Group, Inc.
Mentor, OH, US - Received
- June 20, 2005
- Decision date
- October 31, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FCK – Instrument, Biopsy, Suction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Dsnare, Model 00711087 cleared by the FDA?
Dsnare, Model 00711087 (K051637) received a 510(k) decision of Substantially Equivalent on October 31, 2005, 133 days after the submission was received.
What is the product code of K051637?
The FDA product code is FCK – Instrument, Biopsy, Suction, a Class II (moderate risk) device regulated under 21 CFR 876.1075.