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 Jul 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
Jul 31, 2009
Date Received
Apr 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 (Jun 19, 2002)
  • K020599 — MTP CLEARVISION DISPOSABLE TUBING SET (Mar 13, 2002)
  • K011360 — MTP LAPAROMAT DISPOSABLE TUBING SET (Jul 19, 2001)
  • K000337 — MTP DISPOSABLE TROCAR VALVES (Apr 12, 2000)
  • K994066 — MTP DISPOSABLE TROCARS (Jan 20, 2000)
  • K990912 — MTP EXTRACTION BAG (Jun 9, 1999)
  • K990909 — MTP UROPUMP DISPOSABLE TUBING SET (Jun 9, 1999)
  • K990911 — MTP ARTHROPUMP DISPOSABLE TUBING SET (Jun 3, 1999)
  • K990910 — MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS (Jun 3, 1999)

Other clearances for product code MMP

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

FDA data resources