Panels › Gastroenterology, Urology › Product code FEN · Class 2
Device, Cystometric, Hydraulic
Regulation 876.1620
0510(k)s in 12 months (36 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in FEN
| Company | 510(k)s | Recalls |
|---|---|---|
| Fiberoptic Sensor Technlogies, Inc. | 8 | 0 |
| Laborie Medical Technologies, Corp. | 3 | 2 |
| Life-Tech Intl., Inc. | 5 | 0 |
| Medamicus, Inc. | 3 | 0 |
| Rusch Intl. | 2 | 0 |
| Andromeda Medizinische Systeme GmbH | 1 | 0 |
| C.R. Bard, Inc. | 1 | 0 |
| Circon Video | 1 | 0 |
| ConvaTec, Inc | 0 | 1 |
| Cook Urological, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 2021 | K212830 | CT3000Pro Srs Medical | FEN |
| Dec 18, 2008 | K082701 | URONIRS, MODEL 2000 Urodynamix Technologies, Ltd., CA | FEN |
| Mar 5, 2008 | K073552 | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY Laborie Medical Technologies, Corp. | FEN |
| Jul 17, 2000 | K001386 | ACCUSET SENSOR, MODEL 2000 Pelvicare, Inc. | FEN |
| Feb 28, 2000 | K992715 | NEURO URODYNAMIC SUITE, MODEL 9032E0101 Medtronic Functional Diagnostics A/S, DK | FEN |
| Nov 24, 1998 | K983325 | IN-PROBE II URODYNAMIC SYSTEM Influence, Inc. | FEN |
| Oct 24, 1997 | K970595 | CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP Circon Video | FEN |
| Jun 3, 1997 | K971911 | LUMAX CYSTOMETRY ADMINISTRATION TUBE SET Medamicus, Inc. | FEN |
| Mar 21, 1997 | K964522 | ELLIPSE 4 Andromeda Medizinische Systeme GmbH | FEN |
| Sep 16, 1996 | K960503 | DANTEC DUET Dantec Medical, Inc. | FEN |
| Jan 18, 1996 | K953734 | LUMAX(MODIFICATION) Medamicus, Inc. | FEN |
| Jan 11, 1996 | K954093 | LUMAX (MODIFICATION) Medamicus, Inc. | FEN |
| Nov 30, 1995 | K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER Life-Tech Intl., Inc. | FEN |
| Oct 17, 1995 | K954341 | URODYNAMICS TUBING AND INFUSION SETS Life-Tech Intl., Inc. | FEN |
| Oct 5, 1995 | K953451 | UROPUMP TUBE & DAMPING CHAMGER Life-Tech Intl., Inc. | FEN |
| Sep 8, 1995 | K953353 | UROVISION JANUS Life-Tech Intl., Inc. | FEN |
| Jul 6, 1995 | K951805 | PIPER, MODEL NUMBER UDS-PIPERB Laborie Medical Technologies, Ltd., CA | FEN |
| Jun 15, 1995 | K952573 | RUSCH URODYNAMIC RECTAL BALLOON CATHETER Rusch Intl. | FEN |
| Jun 13, 1995 | K952029 | RUSCH INTERNATIONAL URODYNAMIC CATHETERS Rusch Intl. | FEN |
| May 11, 1995 | K945753 | FST FIBEROPTIC PRESSURE CONVERTER Fiberoptic Sensor Technlogies, Inc. | FEN |
| Apr 7, 1995 | K950908 | FST CATH-UD, CATHETER Fiberoptic Sensor Technlogies, Inc. | FEN |
| Mar 30, 1995 | K950016 | CART, MODE NUMBER UDS-CART Laborie Medical Tech Corp., CA | FEN |
| Feb 7, 1995 | K944391 | OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM Surgitek | FEN |
| Jul 12, 1994 | K942023 | INFUSION PUMP, MODEL NO. UDP-5 Laborie Medical Technologies, Ltd. | FEN |
| Apr 18, 1994 | K936041 | UROGRAM CYSTOMETROGRAM Myo/Kinetic Systems, Inc. | FEN |
| Mar 30, 1994 | K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS Life-Tech Intl., Inc. | FEN |
| Nov 18, 1993 | K934141 | STAND ALONE CYSTOMETROGRAM Medical Engineering Corp. | FEN |
| Nov 4, 1993 | K930171 | FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR Fiberoptic Sensor Technlogies, Inc. | FEN |
| Nov 2, 1993 | K933399 | KENDALL URODYNAMIC CATHETERS Kendall Healthcare Products Co. Div.Of Tyco Health | FEN |
| Oct 8, 1993 | K930135 | SILICONE RECTAL BALLOON Cook Urological, Inc. | FEN |
| Sep 21, 1993 | K924714 | BARD URODYNAMIC CATHETER C.R. Bard, Inc. | FEN |
| Jul 20, 1993 | K922776 | FST COUNCIL TIP FOLEY CATHETER Fiberoptic Sensor Technlogies, Inc. | FEN |
| Jun 18, 1993 | K926088 | FST CATH UD-DUAL DUAL PRESSURE CATHETER Fiberoptic Sensor Technlogies, Inc. | FEN |
| Oct 9, 1991 | K913113 | FST CATH-UD CATHETER, MODIFICATION Fiberoptic Sensor Technlogies, Inc. | FEN |
| Oct 8, 1991 | K913721 | FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM Fiberoptic Sensor Technlogies, Inc. | FEN |
| Feb 19, 1991 | K905641 | FST CATH-UD CATHETER Fiberoptic Sensor Technlogies, Inc. | FEN |
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