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510(k) K931509

GERITREX STERILE SALINE SOLUTION FOR IRRIGATION by Geritrex Corp. — Product Code JOL

K931509 is an FDA 510(k) premarket notification submitted by Geritrex Corp. for the device "GERITREX STERILE SALINE SOLUTION FOR IRRIGATION". The FDA issued a decision of Substantially Equivalent on September 22, 1994. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Geritrex Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1994
Date Received
March 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter And Tip, Suction
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Geritrex Corp.

  • K945224 — GRX FOAM DRESSING (April 3, 1995)
  • K931511 — GERITREX STERILE WATER FOR IRRIGATION (February 14, 1994)
  • K931510 — GERITREX STERILE SALINE WET DRESSING (July 13, 1993)

Other clearances for product code JOL

  • K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F (August 12, 2005)
  • K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (July 12, 2001)
  • K000265 — PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (July 12, 2001)
  • K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FO (May 1, 2001)
  • K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (October 25, 2000)
  • K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (March 9, 1998)
  • K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (March 9, 1998)
  • K974397 — STERILE SALINE FOR CATHETER CARE (February 10, 1998)
  • K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (February 5, 1998)
  • K972372 — GERM TRAPPER SUCTION TUBE HOLDER (December 11, 1997)

FDA data resources