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510(k) K883193

CASF STERILIZATION TRAY by Terray Manufacturing, Inc. — Product Code FSM

K883193 is an FDA 510(k) premarket notification submitted by Terray Manufacturing, Inc. for the device "CASF STERILIZATION TRAY". The FDA issued a decision of Substantially Equivalent on August 10, 1988. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Terray Manufacturing, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1988
Date Received
July 28, 1988
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 Terray Manufacturing, Inc.

  • K910874 — THORACIC ANTERIOR SPINAL FIXATION PLATE (February 3, 1992)
  • K882934 — CASF CANCELLOUS BONE SCREW, BT650 (October 13, 1988)
  • K882871 — CASF DRILL GUIDE DG 170 (September 23, 1988)
  • K883125 — CASF STERILIZATION TRAY (August 10, 1988)
  • K870085 — ANTERIOR SPINAL FIXATION PLATE (June 30, 1987)
  • K870082 — BONE PLATE (May 6, 1987)
  • K870083 — FERRAY EXTRACTOR (February 26, 1987)
  • K870084 — RD 140 SURGICAL BENDER (January 28, 1987)

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