Enteroscope
FDA 510(k) K840722 · Trimedyne, Inc.
510(k) numberK840722
Submission
- Device name
- Enteroscope
- Applicant
- Trimedyne, Inc.
Walker, MI, US - Received
- February 17, 1984
- Decision date
- June 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K213195 | Balloon BS-3FDA · Special | Fujifilm Corporation | 10/29/2021SE |
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| K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFDA · Traditional | Fujifilm Medical Systems U.S.A, Inc. | 08/20/2015SE |
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Questions and answers
When was Enteroscope cleared by the FDA?
Enteroscope (K840722) received a 510(k) decision of Substantially Equivalent on June 7, 1984, 111 days after the submission was received.
What is the product code of K840722?
The FDA product code is FDA – Enteroscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.