Gastro-Intestinal System EN-410WM
FDA 510(k) K993704 · Fujinon, Inc.
510(k) numberK993704
Submission
- Device name
- Gastro-Intestinal System EN-410WM
- Applicant
- Fujinon, Inc.
New York, NY, US - Received
- November 2, 1999
- Decision date
- February 11, 2000
- 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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| K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700FDS · Traditional | 03/01/2007SE |
| K050907 | Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PEOQ · Traditional | 05/19/2005SE |
| K042043 | Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5FDS · Traditional | 11/24/2004SE |
Questions and answers
When was Gastro-Intestinal System EN-410WM cleared by the FDA?
Gastro-Intestinal System EN-410WM (K993704) received a 510(k) decision of Substantially Equivalent on February 11, 2000, 101 days after the submission was received.
What is the product code of K993704?
The FDA product code is FDA – Enteroscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.