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510(k) K842009

ABDOMINAL PARACENTESIS TRAY by Jayco Pharmaceuticals — Product Code FSM

K842009 is an FDA 510(k) premarket notification submitted by Jayco Pharmaceuticals for the device "ABDOMINAL PARACENTESIS TRAY". The FDA issued a decision of Substantially Equivalent on October 23, 1984. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Jayco Pharmaceuticals has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1984
Date Received
May 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Jayco Pharmaceuticals

  • K844691 — ENDOSCOPIC ASPIRATION CATHETER SET (January 2, 1985)
  • K844689 — ENDOSCOPIC MANUAL AIR INSUFFLATOR (January 2, 1985)
  • K844690 — ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT (January 2, 1985)
  • K842001 — LIVER BIOPSY TRAY (October 15, 1984)
  • K841258 — FOREIGN BODY PROTECTOR (July 9, 1984)
  • K840800 — POLYP-SAVER SLEVE (March 23, 1984)
  • K830781 — ENDO-GUARD (March 31, 1983)
  • K810875 — FECAL STAINING KIT (May 1, 1981)

Other clearances for product code FSM

  • K971217 — INSTRUMENT TRAY LINER (May 6, 1997)
  • K962328 — SINGLE USE INSTRUMENT TRAY (August 9, 1996)
  • K944025 — SURGICAL INSTRUMENT TRAY (November 22, 1994)
  • K912106 — ARTHROSCOPY TRAY (August 29, 1991)
  • K912053 — OPEN HEART TRAY (August 26, 1991)
  • K912052 — HEART CATH TRAY (August 20, 1991)
  • K912104 — MAJOR BASIN TRAY (August 9, 1991)
  • K910570 — SPLINTER TWEEZERS (May 31, 1991)
  • K911601 — REDDICK TROCAR AND CANNULA (May 21, 1991)
  • K910328 — KEY COMFORT GRIPS (March 6, 1991)

FDA data resources