Esophageal Motility Tube
FDA 510(k) K760761 · Sherwood Medical Industries
510(k) numberK760761
Submission
- Device name
- Esophageal Motility Tube
- Applicant
- Sherwood Medical Industries
Mchenry, IL, US - Received
- October 4, 1976
- Decision date
- November 30, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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| K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)FFX · Traditional | Medspira, LLC | 12/05/2025SE |
| K240007 | Solar Compact (G4-1)FFX · Traditional | Laborie Medical Technologies, Corp. | 05/06/2024SE |
| K231861 | EndoflipTM 300 SystemFFX · Special | Covidien, LLC | 07/21/2023SE |
| K223705 | EndoflipTM 300FFX · Traditional | Covidien, LLC | 04/14/2023SE |
| K222000 | Transit-PelletsFFX · Traditional | Medifactia AB | 01/18/2023SE |
| K201106 | IntraMarX 3D Radiopaque MarkerFFX · Special | Anx Robotica Corp | 05/21/2020SE |
| K191087 | IntraMarX Radiopaque MarkersFFX · Traditional | Anx Robotica Corp | 12/18/2019SE |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeFFX · Traditional | Diversatek Healthcare | 10/03/2019SE |
| K181760 | Transit-PelletsFFX · Traditional | Medifactia AB | 08/08/2019SE |
| K183072 | EndoFLIP SystemFFX · Traditional | Crospon, Ltd. | 02/15/2019SE |
More from Crospon, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K801070 | Sherwood Disposable Endometrial SamplesHHK · Traditional | 07/21/1980SE |
| K801071 | Lancer Glucose Rate Reagent KitCGA · Traditional | 05/23/1980SE |
| K792014 | Lancer L-Ina Buffer, Polymer, Wash SoluJZW · Traditional | 11/13/1979SE |
| K792013 | Lancer L-Ina Human Reference SerumJIX · Traditional | 11/13/1979SE |
| K782077 | Lancer Ice CubeJRM · Traditional | 04/03/1979SE |
| K790523 | Argyle Esophageal StethoscopeBZW · Traditional | 03/27/1979SE |
| K790196 | Monoject Arterial Blood Sampling DeviceCBT · Traditional | 03/13/1979SE |
| K790197 | Reagent Kit, Lancer GlucoseJJF · Traditional | 03/12/1979SE |
| K781459 | Monoject Scale MagnifierHJY · Traditional | 10/24/1978SE |
| K781060 | Monoject Endosseous Dental ImplantDZE · Traditional | 08/14/1978SE |
Questions and answers
When was Esophageal Motility Tube cleared by the FDA?
Esophageal Motility Tube (K760761) received a 510(k) decision of Substantially Equivalent on November 30, 1976, 57 days after the submission was received.
What is the product code of K760761?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.