FDA Product Code
FDA Product Code FEN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1620
510(k) Clearances — 36 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K212830 | CT3000Pro | Srs Medical | 2021-12-21 | Traditional | PDF ↗ |
| K082701 | URONIRS, MODEL 2000 | Urodynamix Technologies, Ltd. | 2008-12-18 | Traditional | PDF ↗ |
| K073552 | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY | Laborie Medical Technologies, Corp. | 2008-03-05 | Traditional | PDF ↗ |
| K001386 | ACCUSET SENSOR, MODEL 2000 | Pelvicare, Inc. | 2000-07-17 | Traditional | PDF ↗ |
| K992715 | NEURO URODYNAMIC SUITE, MODEL 9032E0101 | Medtronic Functional Diagnostics A/S | 2000-02-28 | Traditional | PDF ↗ |
| K983325 | IN-PROBE II URODYNAMIC SYSTEM | Influence, Inc. | 1998-11-24 | Traditional | PDF ↗ |
| K970595 | CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP | Circon Video | 1997-10-24 | Traditional | PDF ↗ |
| K971911 | LUMAX CYSTOMETRY ADMINISTRATION TUBE SET | Medamicus, Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K964522 | ELLIPSE 4 | Andromeda Medizinische Systeme GmbH | 1997-03-21 | Traditional | PDF ↗ |
| K960503 | DANTEC DUET | Dantec Medical, Inc. | 1996-09-16 | Traditional | PDF ↗ |
| K953734 | LUMAX(MODIFICATION) | Medamicus, Inc. | 1996-01-18 | Traditional | PDF ↗ |
| K954093 | LUMAX (MODIFICATION) | Medamicus, Inc. | 1996-01-11 | Traditional | PDF ↗ |
| K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | Life-Tech Intl., Inc. | 1995-11-30 | Traditional | PDF ↗ |
| K954341 | URODYNAMICS TUBING AND INFUSION SETS | Life-Tech Intl., Inc. | 1995-10-17 | Traditional | PDF ↗ |
| K953451 | UROPUMP TUBE & DAMPING CHAMGER | Life-Tech Intl., Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K953353 | UROVISION JANUS | Life-Tech Intl., Inc. | 1995-09-08 | Traditional | PDF ↗ |
| K951805 | PIPER, MODEL NUMBER UDS-PIPERB | Laborie Medical Technologies, Ltd. | 1995-07-06 | Traditional | PDF ↗ |
| K952573 | RUSCH URODYNAMIC RECTAL BALLOON CATHETER | Rusch Intl. | 1995-06-15 | Traditional | PDF ↗ |
| K952029 | RUSCH INTERNATIONAL URODYNAMIC CATHETERS | Rusch Intl. | 1995-06-13 | Traditional | PDF ↗ |
| K945753 | FST FIBEROPTIC PRESSURE CONVERTER | Fiberoptic Sensor Technlogies, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K950908 | FST CATH-UD, CATHETER | Fiberoptic Sensor Technlogies, Inc. | 1995-04-07 | Traditional | PDF ↗ |
| K950016 | CART, MODE NUMBER UDS-CART | Laborie Medical Tech Corp. | 1995-03-30 | Traditional | PDF ↗ |
| K944391 | OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM | Surgitek | 1995-02-07 | Traditional | PDF ↗ |
| K942023 | INFUSION PUMP, MODEL NO. UDP-5 | Laborie Medical Technologies, Ltd. | 1994-07-12 | Traditional | PDF ↗ |
| K936041 | UROGRAM CYSTOMETROGRAM | Myo/Kinetic Systems, Inc. | 1994-04-18 | Traditional | PDF ↗ |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Life-Tech Intl., Inc. | 1994-03-30 | Traditional | PDF ↗ |
| K934141 | STAND ALONE CYSTOMETROGRAM | Medical Engineering Corp. | 1993-11-18 | Traditional | PDF ↗ |
| K930171 | FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR | Fiberoptic Sensor Technlogies, Inc. | 1993-11-04 | Traditional | PDF ↗ |
| K933399 | KENDALL URODYNAMIC CATHETERS | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-11-02 | Traditional | PDF ↗ |
| K930135 | SILICONE RECTAL BALLOON | Cook Urological, Inc. | 1993-10-08 | Traditional | PDF ↗ |
| K924714 | BARD URODYNAMIC CATHETER | C.R. Bard, Inc. | 1993-09-21 | Traditional | PDF ↗ |
| K922776 | FST COUNCIL TIP FOLEY CATHETER | Fiberoptic Sensor Technlogies, Inc. | 1993-07-20 | Traditional | PDF ↗ |
| K926088 | FST CATH UD-DUAL DUAL PRESSURE CATHETER | Fiberoptic Sensor Technlogies, Inc. | 1993-06-18 | Traditional | PDF ↗ |
| K913113 | FST CATH-UD CATHETER, MODIFICATION | Fiberoptic Sensor Technlogies, Inc. | 1991-10-09 | Traditional | PDF ↗ |
| K913721 | FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM | Fiberoptic Sensor Technlogies, Inc. | 1991-10-08 | Traditional | PDF ↗ |
| K905641 | FST CATH-UD CATHETER | Fiberoptic Sensor Technlogies, Inc. | 1991-02-19 | Traditional | PDF ↗ |
Product code FEN · Class II · Gastroenterology, Urology. Data: openFDA.