Zinetics Amc
FDA 510(k) K921682 · Zinetics Medical, Inc.
510(k) numberK921682
Submission
- Device name
- Zinetics Amc
- Applicant
- Zinetics Medical, Inc.
Salt Lake City, UT, US - Received
- April 8, 1992
- Decision date
- December 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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.
Questions and answers
When was Zinetics Amc cleared by the FDA?
Zinetics Amc (K921682) received a 510(k) decision of Substantially Equivalent on December 29, 1994, 995 days after the submission was received.
What is the product code of K921682?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.