Ano-Rectal Manometry Option, Model Number Uds-Arm
FDA 510(k) K963064 · Laborie Medical Tech Corp.
510(k) numberK963064
Submission
- Device name
- Ano-Rectal Manometry Option, Model Number Uds-Arm
- Applicant
- Laborie Medical Tech Corp.
Williston, VT, US - Received
- August 7, 1996
- Decision date
- June 5, 1997
- 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
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| K231861 | EndoflipTM 300 SystemFFX · Special | Covidien, LLC | 07/21/2023SE |
| K223705 | EndoflipTM 300FFX · Traditional | Covidien, LLC | 04/14/2023SE |
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| 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 |
|---|---|---|
| K993721 | Urostym Biofeedback and Stimulation Anal/Rectal ProbesKPI · Abbreviated | 11/29/1999SE |
| K990041 | Urostym Biofeedback and Stimulation ProbesKPI · Traditional | 08/05/1999SE |
| K991479 | Viser Penile Tumescence MonitorLIL · Traditional | 07/07/1999SE |
| K950016 | Cart, Mode Number Uds-CartFEN · Traditional | 03/30/1995SE |
| K941105 | Uorcap,Model Number Uds-UcapEXY · Traditional | 05/10/1994SE |
Questions and answers
When was Ano-Rectal Manometry Option, Model Number Uds-Arm cleared by the FDA?
Ano-Rectal Manometry Option, Model Number Uds-Arm (K963064) received a 510(k) decision of Substantially Equivalent on June 5, 1997, 302 days after the submission was received.
What is the product code of K963064?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.