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510(k) K840323

SILICONE SUCTION & IRRIGATION DRAIN by Superior Plastic Products Corp. — Product Code GBX

K840323 is an FDA 510(k) premarket notification submitted by Superior Plastic Products Corp. for the device "SILICONE SUCTION & IRRIGATION DRAIN". The FDA issued a decision of Substantially Equivalent on April 25, 1984. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. Superior Plastic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1984
Date Received
January 25, 1984
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 Superior Plastic Products Corp.

  • K851981 — NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC. (June 18, 1985)
  • K843975 — 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE (November 20, 1984)
  • K841945 — ENTERAL FEEDING BOTTLE (July 26, 1984)
  • K841630 — ENTERAL NUTRITION PUMP (June 7, 1984)
  • K841480 — INFECTION CONTROL VALVE (April 25, 1984)
  • K840324 — SILICONE SUMP DRAIN 20 & 40 FRENCH (April 25, 1984)
  • K833687 — DISPOS. ENTERIC FEEDING TUBES W/SAFE-T (March 2, 1984)
  • K833947 — SUPERIOR ENTERNAL FEEDING SYSTEM (February 4, 1984)
  • K820460 — 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION (March 8, 1982)
  • K812312 — STERILE WATER 4OZ. (November 13, 1981)

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