GastroFlush
FDA 510(k) K180605 · Bionix Development Corporation
510(k) numberK180605
Submission
- Device name
- GastroFlush
- Applicant
- Bionix Development Corporation
Toledo, OH, US - Received
- March 7, 2018
- Decision date
- October 24, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | C.R. Bard, Inc. | 07/10/2026SE |
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| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT…KNT · Traditional | Tools For Surgery, LLC | 01/10/2025SE |
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| K933614 | Pituitary BoardIYE · Traditional | 10/07/1993SE |
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Questions and answers
When was GastroFlush cleared by the FDA?
GastroFlush (K180605) received a 510(k) decision of Substantially Equivalent on October 24, 2018, 231 days after the submission was received.
What is the product code of K180605?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.