Home / 510(k) Clearances / K091178

510(k) K091178

MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN by Mtp Medical Technical Promotion GmbH — Product Code MMP

K091178 is an FDA 510(k) premarket notification submitted by Mtp Medical Technical Promotion GmbH for the device "MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN". The FDA issued a decision of Substantially Equivalent on July 31, 2009. The device falls under product code MMP (Cover, Barrier, Protective), a Class II device regulated under 21 CFR 878.4370. Mtp Medical Technical Promotion GmbH has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2009
Date Received
April 22, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Barrier, Protective
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Mtp Medical Technical Promotion GmbH

  • 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)
  • K990909 — MTP UROPUMP DISPOSABLE TUBING SET (June 9, 1999)
  • K990910 — MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS (June 3, 1999)
  • K990911 — MTP ARTHROPUMP DISPOSABLE TUBING SET (June 3, 1999)

Other clearances for product code MMP

  • K043234 — LIGHT DRAPE (May 25, 2005)
  • K041501 — GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS (November 30, 2004)
  • K040794 — INCUBATOR CAPE (June 10, 2004)
  • K032065 — MEDLINE BAND BAGS AND EQUIPMENT COVERS (September 22, 2003)
  • K023540 — SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 (February 4, 2003)
  • K014239 — MEDSURG EQUIPMENT COVERS (February 19, 2002)
  • K970885 — ULTRASOUND SYSTEMS DRAPE (September 22, 1997)
  • K962288 — COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER (January 30, 1997)
  • K961699 — EQUIPMENT COVERS (August 23, 1996)
  • K952241 — PROTOUCH OVERGLOVE (August 7, 1995)

FDA data resources