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510(k) K955019

UROTRACT I by Dornier Medtech America, Inc. — Product Code KQS

K955019 is an FDA 510(k) premarket notification submitted by Dornier Medtech America, Inc. for the device "UROTRACT I". The FDA issued a decision of Substantially Equivalent on December 6, 1995. The device falls under product code KQS (Table, Cystometric, Non-Electric And Accessories), a Class I device regulated under 21 CFR 876.4890. Dornier Medtech America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1995
Date Received
November 2, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Cystometric, Non-Electric And Accessories
Device Class
Class I
Regulation Number
876.4890
Review Panel
GU
Submission Type

Other clearances by Dornier Medtech America, Inc.

  • K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, I (January 31, 2025)
  • K233380 — TRIDENT Mobile Fluoroscopy System (June 26, 2024)
  • K221903 — Delta III Pro (February 22, 2023)
  • K213252 — Dornier Thulio (July 27, 2022)
  • K220871 — Nautilus (April 18, 2022)
  • K210394 — Electrosurgical accessory (May 19, 2021)
  • K201815 — Dornier MAGELLAN Ureteral Access Sheath (November 20, 2020)
  • K201074 — Delta III Lithotripter (September 3, 2020)
  • K190612 — EQUINOX Balloon Dilatation Catheter (December 6, 2019)
  • K190312 — Dornier Ureteral Stent (November 15, 2019)

Other clearances for product code KQS

  • K872022 — UROVIEW (July 16, 1987)
  • K864846 — RADIOGRAPHIC - LEG SECTION (December 24, 1986)
  • K860040 — HYDRAJUST III UROLOGICAL TABLE (February 10, 1986)
  • K852127 — AMSCO URO-ENDO MOBILE TABLE (August 8, 1985)
  • K801723 — UR 150-UR 150T (August 13, 1980)
  • K791699 — HYDRADJUST II UROLOGICAL TABLE (October 22, 1979)
  • K760522 — TABLE, UROSURGICAL (December 16, 1976)

FDA data resources