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510(k) K905766

DRAINAGE TUBE RESTRAINT/WOUND COVER by M. Imonti and Associates Inc., — Product Code GBX

K905766 is an FDA 510(k) premarket notification submitted by M. Imonti and Associates Inc., for the device "DRAINAGE TUBE RESTRAINT/WOUND COVER". The FDA issued a decision of Substantially Equivalent on March 6, 1991. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. M. Imonti and Associates Inc., has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1991
Date Received
December 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by M. Imonti and Associates Inc.,

  • K950800 — PRO-PAK FOR OMS DIPLOMATE (May 22, 1995)
  • K950799 — PRO-VIT (April 28, 1995)
  • K933627 — PHACOFRAGMENTOR TIP (January 25, 1994)
  • K933503 — PRO-PHACO HANDPIECE (January 6, 1994)
  • K924551 — ENDO TRACHEA TUBE FIXATION (December 8, 1992)

Other clearances for product code GBX

  • K131659 — MOERAE VEIN PREPARATION KIT (March 3, 2014)
  • K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE (December 17, 2008)
  • K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (October 21, 2005)
  • K043515 — GRAFTSAVER (March 31, 2005)
  • K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P (January 10, 2002)
  • K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (May 19, 2000)
  • K974233 — LYSONIX IRRIGATION SYSTEM (February 3, 1998)
  • K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (December 4, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (March 10, 1997)

FDA data resources