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510(k) K771079

CURITY IRRIGATION TRAY by Kendall Research Center — Product Code GBX

K771079 is an FDA 510(k) premarket notification submitted by Kendall Research Center for the device "CURITY IRRIGATION TRAY". The FDA issued a decision of Substantially Equivalent on September 15, 1977. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. Kendall Research Center has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1977
Date Received
June 15, 1977
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 Kendall Research Center

  • K802225 — TENDER-SORB DRAIN SPONGES (September 26, 1980)
  • K781357 — T.E.D. SEQUENTIAL COMPRESSION SLEEVES (September 20, 1978)
  • K780408 — MICRONET LIGHT DRESSING SPONGE (March 22, 1978)
  • K780062 — CATHETER/HEMOSTATIC/GERIATRIC (February 14, 1978)
  • K780120 — ANESTHESIA TRAY, CAUDAL (February 6, 1978)
  • K772134 — SYRINGE, IRRIGATION, PRE-FILLED (November 28, 1977)
  • K772133 — URINE SPECIMEN COLLECTING DEVICE (November 28, 1977)
  • K771655 — CURITY PEAKOMETER (October 14, 1977)
  • K771563 — CONFORM ELASTIC NETTING (September 12, 1977)
  • K771452 — CONFORM STRETCH BANDAGE (5SIZES) (September 12, 1977)

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