Lehman Manometry Catheter
FDA 510(k) K160170 · Wilson-Cook Medical, Inc.
510(k) numberK160170
Submission
- Device name
- Lehman Manometry Catheter
- Applicant
- Wilson-Cook Medical, Inc.
Winston-Salem, NC, US - Received
- January 27, 2016
- Decision date
- June 20, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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.
| 510(k) | Device | Decision |
|---|---|---|
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X])QAU · Traditional | 06/02/2026SE |
| K251104 | SureTome SW Sphincterotome with DomeTipKNS · Traditional | 09/29/2025SE |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordKNS · Special | 01/17/2025SE |
| K213483 | SnapLoc Wire LockODC · Traditional | 04/26/2022SE |
| K213356 | Entuit PEG, Entuit PEGJPIF · Special | 01/20/2022SESD |
| K212323 | Instinct Plus Endoscopic Clipping DevicePKL · Special | 08/25/2021SE |
| K201322 | Entuit Nasal Jejunal Feeding TubeKNT · Special | 06/17/2020SESK |
| K200972 | Hemospray Endoscopic HemostatQAU · Traditional | 06/10/2020SE |
| K200247 | Fusion Quattro Extraction BalloonGCA · Special | 02/27/2020SE |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordKNS · Traditional | 01/30/2020SE |
Questions and answers
When was Lehman Manometry Catheter cleared by the FDA?
Lehman Manometry Catheter (K160170) received a 510(k) decision of Substantially Equivalent on June 20, 2016, 145 days after the submission was received.
What is the product code of K160170?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.