GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
FDA 510(k) K160654 · Covidien, LLC
510(k) numberK160654
Submission
- Device name
- GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
- Applicant
- Covidien, LLC
North Haven, CT, US - Received
- March 8, 2016
- Decision date
- May 4, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K240965 | CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional | Avanos Medical, Inc. | 06/06/2024SE |
| K233591 | StylusKNT · Traditional | Degania Silicone , Ltd. | 05/31/2024SE |
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| K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043…BZT · Traditional | 12/29/2025SE |
| K250725 | Hugo RAS SystemSCV · Traditional | 12/03/2025SE |
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| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley…BTR · Traditional | 09/25/2025SE |
| K241486 | Sofsilk Coated Braided Silk SutureGAP · Traditional | 12/03/2024SE |
Questions and answers
When was GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) cleared by the FDA?
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) (K160654) received a 510(k) decision of Substantially Equivalent on May 4, 2016, 57 days after the submission was received.
What is the product code of K160654?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.