Product Code: FEN
FDA class 2
21 CFR 876.1620
Device, Cystometric, Hydraulic
Gastroenterology, Urology
The Hydraulic Cystometric Device is used to measure the pressure-volume relationship of the urinary bladder, providing diagnostic information about bladder function and dysfunction. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is FEN, regulated under 21 CFR 876.1620, within the Gastroenterology, Urology medical specialty.
510(k)s
36
FEI Numbers
56
Registration Numbers
56
Unique Applicants
21
Years Active
31
Basic Information
- Product Code
- FEN
- Device Class
- FDA class 2
- Regulation Number
- 876.1620
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 36 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K212830 | CT3000Pro | Dec 21, 2021 | Substantially Equivalent | SRS Medical |
| K082701 | URONIRS, MODEL 2000 | Dec 18, 2008 | Substantially Equivalent | URODYNAMIX TECHNOLOGIES LTD |
| K073552 | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY | Mar 05, 2008 | Substantially Equivalent | LABORIE MEDICAL TECHNOLOGIES, CORP |
| K001386 | ACCUSET SENSOR, MODEL 2000 | Jul 17, 2000 | Substantially Equivalent | PELVICARE, INC. |
| K992715 | NEURO URODYNAMIC SUITE, MODEL 9032E0101 | Feb 28, 2000 | Substantially Equivalent | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
| K983325 | IN-PROBE II URODYNAMIC SYSTEM | Nov 24, 1998 | Substantially Equivalent | INFLUENCE, INC. |
| K970595 | CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP | Oct 24, 1997 | Substantially Equivalent | CIRCON VIDEO |
| K971911 | LUMAX CYSTOMETRY ADMINISTRATION TUBE SET | Jun 03, 1997 | Substantially Equivalent | MEDAMICUS, INC. |
| K964522 | ELLIPSE 4 | Mar 21, 1997 | Substantially Equivalent | ANDROMEDA MEDIZINISCHE SYSTEME GMBH |
| K960503 | DANTEC DUET | Sep 16, 1996 | Substantially Equivalent | DANTEC MEDICAL, INC. |
| K953734 | LUMAX(MODIFICATION) | Jan 18, 1996 | Substantially Equivalent | MEDAMICUS, INC. |
| K954093 | LUMAX (MODIFICATION) | Jan 11, 1996 | Substantially Equivalent | MEDAMICUS, INC. |
| K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | Nov 30, 1995 | Substantially Equivalent | LIFE-TECH INTL., INC. |
| K954341 | URODYNAMICS TUBING AND INFUSION SETS | Oct 17, 1995 | Substantially Equivalent | LIFE-TECH INTL., INC. |
| K953451 | UROPUMP TUBE & DAMPING CHAMGER | Oct 05, 1995 | Substantially Equivalent | LIFE-TECH INTL., INC. |
| K953353 | UROVISION JANUS | Sep 08, 1995 | Substantially Equivalent | LIFE-TECH INTL., INC. |
| K951805 | PIPER, MODEL NUMBER UDS-PIPERB | Jul 06, 1995 | Substantially Equivalent | LABORIE MEDICAL TECHNOLOGIES, LTD. |
| K952573 | RUSCH URODYNAMIC RECTAL BALLOON CATHETER | Jun 15, 1995 | Substantially Equivalent | RUSCH INTL. |
| K952029 | RUSCH INTERNATIONAL URODYNAMIC CATHETERS | Jun 13, 1995 | Substantially Equivalent | RUSCH INTL. |
| K945753 | FST FIBEROPTIC PRESSURE CONVERTER | May 11, 1995 | Substantially Equivalent | FIBEROPTIC SENSOR TECHNLOGIES, INC. |
| K950908 | FST CATH-UD, CATHETER | Apr 07, 1995 | Substantially Equivalent | FIBEROPTIC SENSOR TECHNLOGIES, INC. |
| K950016 | CART, MODE NUMBER UDS-CART | Mar 30, 1995 | Substantially Equivalent | LABORIE MEDICAL TECH CORP. |
| K944391 | OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM | Feb 07, 1995 | Substantially Equivalent | SURGITEK |
| K942023 | INFUSION PUMP, MODEL NO. UDP-5 | Jul 12, 1994 | Substantially Equivalent | LABORIE MEDICAL TECHNOLOGIES, LTD. |
| K936041 | UROGRAM CYSTOMETROGRAM | Apr 18, 1994 | Substantially Equivalent | MYO/KINETIC SYSTEMS, INC. |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Mar 30, 1994 | Substantially Equivalent | LIFE-TECH INTL., INC. |
| K934141 | STAND ALONE CYSTOMETROGRAM | Nov 18, 1993 | Substantially Equivalent | MEDICAL ENGINEERING CORP. |
| K930171 | FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR | Nov 04, 1993 | Substantially Equivalent | FIBEROPTIC SENSOR TECHNLOGIES, INC. |
| K933399 | KENDALL URODYNAMIC CATHETERS | Nov 02, 1993 | Substantially Equivalent | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
| K930135 | SILICONE RECTAL BALLOON | Oct 08, 1993 | Substantially Equivalent | COOK UROLOGICAL, INC. |
| K924714 | BARD URODYNAMIC CATHETER | Sep 21, 1993 | Substantially Equivalent | C.R. BARD, INC. |
| K922776 | FST COUNCIL TIP FOLEY CATHETER | Jul 20, 1993 | Substantially Equivalent | FIBEROPTIC SENSOR TECHNLOGIES, INC. |
| K926088 | FST CATH UD-DUAL DUAL PRESSURE CATHETER | Jun 18, 1993 | Substantially Equivalent | FIBEROPTIC SENSOR TECHNLOGIES, INC. |
| K913113 | FST CATH-UD CATHETER, MODIFICATION | Oct 09, 1991 | Substantially Equivalent | FIBEROPTIC SENSOR TECHNLOGIES, INC. |
| K913721 | FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM | Oct 08, 1991 | Substantially Equivalent | FIBEROPTIC SENSOR TECHNLOGIES, INC. |
| K905641 | FST CATH-UD CATHETER | Feb 19, 1991 | Substantially Equivalent | FIBEROPTIC SENSOR TECHNLOGIES, INC. |
FEI Numbers
This FDA classification entry is associated with 56 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 56 registration numbers. Click on an entry to view related FDA registrations.