Product code FEN— Gastroenterology, Urology
ACCUSET SENSOR, MODEL 2000
- Classification name
- Device, Cystometric, Hydraulic
- Device class
- Class 2
- Regulation
- 21 CFR 876.1620
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 36
- First cleared
- Most recent
Market context for product code FEN
FDA has cleared devices under product code FEN between 1991 and 2021, filed by 21 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2021
- 2008
- 2000
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1991
Top applicants under product code FEN
Recent clearances under product code FEN
- K212830 — CT3000Pro
- K082701 — URONIRS, MODEL 2000
- K073552 — LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
- K001386 — ACCUSET SENSOR, MODEL 2000
- K992715 — NEURO URODYNAMIC SUITE, MODEL 9032E0101
- K983325 — IN-PROBE II URODYNAMIC SYSTEM
- K970595 — CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
- K971911 — LUMAX CYSTOMETRY ADMINISTRATION TUBE SET
- K964522 — ELLIPSE 4
- K960503 — DANTEC DUET
- K953734 — LUMAX(MODIFICATION)
- K954093 — LUMAX (MODIFICATION)
- K954315 — PVC ABDOMINAL/RECTAL PRESSURE CATHETER
- K954341 — URODYNAMICS TUBING AND INFUSION SETS
- K953451 — UROPUMP TUBE & DAMPING CHAMGER
- K953353 — UROVISION JANUS
- K951805 — PIPER, MODEL NUMBER UDS-PIPERB
- K952573 — RUSCH URODYNAMIC RECTAL BALLOON CATHETER
- K952029 — RUSCH INTERNATIONAL URODYNAMIC CATHETERS
- K945753 — FST FIBEROPTIC PRESSURE CONVERTER
- K950908 — FST CATH-UD, CATHETER
- K950016 — CART, MODE NUMBER UDS-CART
- K944391 — OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM
- K942023 — INFUSION PUMP, MODEL NO. UDP-5
- K936041 — UROGRAM CYSTOMETROGRAM
- K940203 — TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS
- K934141 — STAND ALONE CYSTOMETROGRAM
- K930171 — FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR
- K933399 — KENDALL URODYNAMIC CATHETERS
- K930135 — SILICONE RECTAL BALLOON
- K924714 — BARD URODYNAMIC CATHETER
- K922776 — FST COUNCIL TIP FOLEY CATHETER
- K926088 — FST CATH UD-DUAL DUAL PRESSURE CATHETER
- K913113 — FST CATH-UD CATHETER, MODIFICATION
- K913721 — FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM
- K905641 — FST CATH-UD CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.