AutoCap RX
FDA 510(k) K210353 · Boston Scientific Corporation
510(k) numberK210353
Submission
- Device name
- AutoCap RX
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- February 8, 2021
- Decision date
- May 6, 2021
- 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 AutoCap RX cleared by the FDA?
AutoCap RX (K210353) received a 510(k) decision of Substantially Equivalent on May 6, 2021, 87 days after the submission was received.
What is the product code of K210353?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.