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510(k) K983325

IN-PROBE II URODYNAMIC SYSTEM by Influence, Inc. — Product Code FEN

K983325 is an FDA 510(k) premarket notification submitted by Influence, Inc. for the device "IN-PROBE II URODYNAMIC SYSTEM". The FDA issued a decision of Substantially Equivalent on November 24, 1998. The device falls under product code FEN (Device, Cystometric, Hydraulic), a Class II device regulated under 21 CFR 876.1620. Influence, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1998
Date Received
September 22, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Cystometric, Hydraulic
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances by Influence, Inc.

  • K981677 — REPOSE BONE SCREW SYSTEM (August 27, 1999)
  • K991792 — CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE (August 12, 1999)
  • K992277 — STAPLETAC BONE ANCHOR SYSTEM (July 30, 1999)
  • K991122 — CRYO-MONO CRYOGRNIC SYSTEM (July 1, 1999)
  • K990160 — MICROTAC-BONE ANCHOR SYSTEM (February 16, 1999)
  • K990095 — STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM (February 1, 1999)
  • K982155 — SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM (August 31, 1998)
  • K981631 — INFLUENCE CLIP SYSTEM (July 28, 1998)
  • K980482 — TRIANGLE SLING (March 27, 1998)
  • K972622 — STRAIGHT-IN BONE SCREW FIXATION SYSTEM (October 9, 1997)

Other clearances for product code FEN

  • K212830 — CT3000Pro (December 21, 2021)
  • K082701 — URONIRS, MODEL 2000 (December 18, 2008)
  • K073552 — LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY (March 5, 2008)
  • K001386 — ACCUSET SENSOR, MODEL 2000 (July 17, 2000)
  • K992715 — NEURO URODYNAMIC SUITE, MODEL 9032E0101 (February 28, 2000)
  • K970595 — CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP (October 24, 1997)
  • K971911 — LUMAX CYSTOMETRY ADMINISTRATION TUBE SET (June 3, 1997)
  • K964522 — ELLIPSE 4 (March 21, 1997)
  • K960503 — DANTEC DUET (September 16, 1996)
  • K953734 — LUMAX(MODIFICATION) (January 18, 1996)

FDA data resources