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510(k) K893527

LAPAROSCOPIC SUCTION PROBE by Dexide, Inc. — Product Code JOL

K893527 is an FDA 510(k) premarket notification submitted by Dexide, Inc. for the device "LAPAROSCOPIC SUCTION PROBE". The FDA issued a decision of Substantially Equivalent on July 14, 1989. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Dexide, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1989
Date Received
May 8, 1989
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 Dexide, Inc.

  • K991814 — MULTACHOICE INSTRUMENTS (June 23, 1999)
  • K990379 — MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES (March 4, 1999)
  • K981940 — MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES (September 25, 1998)
  • K981941 — MULTAPORT CANNULA REDUCER AND ACCESSORIES (July 29, 1998)
  • K953611 — DEXIDE ENDO-LUBE KIT (September 15, 1995)
  • K944509 — DEXIDE INSUFFLATION TUBING WITH FILTER (February 7, 1995)
  • K924117 — DEXIDE LAPAROSCOPIC KITS (March 23, 1993)
  • K923845 — DEXIDE LAPAROSCOPIC ACCESSORIES (November 25, 1992)
  • K921709 — ENDOBAG, MODIFICATION (July 14, 1992)
  • K913762 — MONOSCOPY(TM) BRAND, ENDOBAG (October 28, 1991)

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)
  • K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (March 9, 1998)
  • K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 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