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510(k) K990909

MTP UROPUMP DISPOSABLE TUBING SET by Mtp Medical Technical Promotion GmbH — Product Code LJH

K990909 is an FDA 510(k) premarket notification submitted by Mtp Medical Technical Promotion GmbH for the device "MTP UROPUMP DISPOSABLE TUBING SET". The FDA issued a decision of Substantially Equivalent on June 9, 1999. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. Mtp Medical Technical Promotion GmbH has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1999
Date Received
March 18, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Irrigation, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Mtp Medical Technical Promotion GmbH

  • K091178 — MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (July 31, 2009)
  • K021811 — UNIDRIVE II PLUS DISPOSABLE TUBING SET (June 19, 2002)
  • K020599 — MTP CLEARVISION DISPOSABLE TUBING SET (March 13, 2002)
  • K011360 — MTP LAPAROMAT DISPOSABLE TUBING SET (July 19, 2001)
  • K000337 — MTP DISPOSABLE TROCAR VALVES (April 12, 2000)
  • K994066 — MTP DISPOSABLE TROCARS (January 20, 2000)
  • K990912 — MTP EXTRACTION BAG (June 9, 1999)
  • K990911 — MTP ARTHROPUMP DISPOSABLE TUBING SET (June 3, 1999)
  • K990910 — MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS (June 3, 1999)

Other clearances for product code LJH

  • K162992 — Karl Storz UROMAT E.A.S.I. (July 7, 2017)
  • K070873 — AMSURE BLADDER IRRIGATION SET (December 19, 2007)
  • K071832 — MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM (September 18, 2007)
  • K063700 — SPYGLASS IRRIGATION SYSTEM (February 8, 2007)
  • K062551 — NEXUS IRRIGATION TUBING SET (December 15, 2006)
  • K042457 — URO PRO (October 25, 2004)
  • K040094 — PIGGYBACK IRRIGATING SYSTEM (April 15, 2004)
  • K023808 — IRRIGATION SETS (March 10, 2003)
  • K010607 — MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 (November 28, 2001)
  • K010122 — CONTINUOUS FLOW Y-TUBING (June 4, 2001)

FDA data resources