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510(k) K936041

UROGRAM CYSTOMETROGRAM by Myo/Kinetic Systems, Inc. — Product Code FEN

K936041 is an FDA 510(k) premarket notification submitted by Myo/Kinetic Systems, Inc. for the device "UROGRAM CYSTOMETROGRAM". The FDA issued a decision of Substantially Equivalent on April 18, 1994. The device falls under product code FEN (Device, Cystometric, Hydraulic), a Class II device regulated under 21 CFR 876.1620. Myo/Kinetic Systems, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1994
Date Received
December 20, 1993
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 Myo/Kinetic Systems, Inc.

  • K945937 — TE-800 PELVIC FLOOR EXERCISER (July 14, 1995)
  • K945292 — TS-700P CONTROL XP ELECTRICAL STIMULATOR (April 12, 1995)
  • K944972 — URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY (March 8, 1995)
  • K932611 — NEUROMUSCULAR STIMULATOR (January 31, 1994)
  • K932764 — THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) (October 1, 1993)
  • K932399 — THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P) (August 11, 1993)
  • K914904 — THERAPEUTIC STIMULATOR 2100 (TS-2100) (April 28, 1992)

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)
  • K983325 — IN-PROBE II URODYNAMIC SYSTEM (November 24, 1998)
  • 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)

FDA data resources