Arc Enterocuff
FDA 510(k) K191330 · Boddingtons Plastics, Ltd.
510(k) numberK191330
Submission
- Device name
- Arc Enterocuff
- Applicant
- Boddingtons Plastics, Ltd.
Tonbridge, GB - Received
- May 16, 2019
- Decision date
- January 31, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FDA – Enteroscope And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K071254 | Small Intestinal Videoscope SystemFDA · Traditional | Olympus Medical Systems Corporation | 03/25/2008SE |
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Questions and answers
When was Arc Enterocuff cleared by the FDA?
Arc Enterocuff (K191330) received a 510(k) decision of Substantially Equivalent on January 31, 2020, 260 days after the submission was received.
What is the product code of K191330?
The FDA product code is FDA – Enteroscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.