ORISE Tissue Retractor System
FDA 510(k) K173400 · Boston Scientific
510(k) numberK173400
Submission
- Device name
- ORISE Tissue Retractor System
- Applicant
- Boston Scientific
Marlboro, MA, US - Received
- October 31, 2017
- Decision date
- February 9, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FED – Endoscopic Access Overtube, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
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Questions and answers
When was ORISE Tissue Retractor System cleared by the FDA?
ORISE Tissue Retractor System (K173400) received a 510(k) decision of Substantially Equivalent on February 9, 2018, 101 days after the submission was received.
What is the product code of K173400?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.